DOWNLOAD THE RECRUITMENT PACKAGE IN YOUR LANGUAGE
English [PDF]
Traditional Chinese (正體字) [PDF]
Simplified Chinese (简化字) [PDF]
Spanish (Español) [PDF]

Ovarian Cancer Early Diagnosis Project

A collaboration with Professor Touradj Solouki, PhD, of Baylor University

PATIENT RECRUITMENT
We invite you to be a research volunteer, to help in the discovery of a new non-invasive test for ovarian cancer. If you are a woman who either:

» Has newly diagnosed or recurrent biopsy-confirmed ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, and has not yet begun treatment, or…
» Has been previously treated and now have a rising CA-125 but has not yet resumed treatment…

We would like to obtain samples of your exhaled breath. We will analyze those breath samples for substances called biomarkers that may be useful in diagnosing these medical problems.

120 women are needed to participate in this research trial.

Our primary goal is to analyze samples of exhaled breath for molecules that could identify ovarian cancer. We will collect samples of exhaled breath using a simple noninvasive device. Those exhaled breath samples will be analyzed using both a chemical method called GC/MS and a biological method (professionally trained dogs). Note: You will not be “sniffed” by the dogs directly. They will be sniffing the breath sample you provide, at a different location.

You may have heard of our prior work using dogs to detect lung and breast cancer, broadcast on CNN and the Discovery Channel.

Our team will be the first to use analysis of exhaled breath to research the diagnosis of ovarian cancer. We expect that this work will lead to progress in the way epithelial ovarian cancer is detected and diagnosed

It is simple and it is easy to participate. We ask only that you visit our research office, to breathe into our simple, safe, and non-invasive collection device. We will also ask you to have your doctor send us some of your medical records.

The study will last two years, and will involve up to 4 visits to San Anselmo, California. A travel stipend of up to $25 per visit will be provided if requested.

To learn more about this clinical research study, please contact us.

This research is sponsored by the Congressionally Mandated Medical Research Program. This study is being conducted by the Pine Street Foundation in collaboration with the University of Maine and UCSF. Our research is governed by strict ethical guidelines as set forth by our Institutional Review Board.

HOW TO PARTICIPATE AS A PATIENT OR CONTROL
1. Download and read the recruitment package:
English [PDF]
Traditional Chinese (正體字) [PDF]
Simplified Chinese (简化字) [PDF]
Spanish (Español) [PDF]

2. Complete and Return the Questionairre (enclosed in the recruitment package) to the Pine Street Foundation

IF YOU HAVE ADDITIONAL QUESTIONS OR ARE UNABLE TO DOWNLOAD THE RECRUITMENT PACKAGE, PLEASE CALL OUR RECRUITMENT HOTLINE AT (415) 407-1357 or SEND A MESSAGE:

[contact-form-7]

Is there meaningful information contained within a person’s breath? Could this information lead to early detection of ovarian cancer? The Pine Street Foundation is seeking to answer these questions with novel, ground-breaking research.

Frequently Asked Questions
Can dogs really detect cancer? How did you collect breath samples? Click here for answers to these questions and more.

Canine Scent Detection of Ovarian Cancer
This study is currently in progress. Click here for the latest on this study as well as how you can participate.

Canine Scent Detection of Lung and Breast Cancer
This ground-breaking study was published in 2006. Click here for more information about this research as well as the full paper.

Click here to listen to the interview

We are doing this with sophisticated chemical analysis at Dr. Solouki’s University of Maine laboratory and with a team of trained dogs at the Pine Street Foundation’s offices in California. We also hope the results of our research will help to predict whether a woman’s ovarian cancer will recur after treatment or become resistant to treatment.

Recruitment Update
So far, over 200 women have contacted us seeking to become enrolled in the study. Of those, 94 are currently eligible and include 13 women with ovarian cancer, 54 healthy controls, and 7 controls with endometriosis or polycystic ovarian syndrome. Study enrollment is still open for non-smoking women who have ovarian, fallopian tube or primary peritoneal cancer (newly diagnosed or recurrent), endometriosis, or polycystic ovarian syndrome. Click here to find out how you can donate a sample of your breath.

Canine Update
At the Pine Street Foundation’s training location, we have been training a team of five dogs, all of whom have reached the most advanced level of our training program. We will soon begin the post-training testing phase of the program, where we’ll be gathering the data that will be reported in scientific publications.

Laboratory Update
Dr. Solouki and his team at the University of Maine have worked diligently to continue to push the sensitivity of the analytical equipment, further increasing our ability to detect meaningful ovarian cancer biomarkers at ever lower concentrations. Dr. Solouki recently joined Michael McCulloch, the Pine Street Foundation’s Director of Research, at a conference sponsored by the Canary Foundation to present a poster session on our exhaled breath analysis study.

How You Can Become Involved
This study is open for enrollment until December 31, 2009. You can also become involved in the study by volunteering to donate a sample of your breath as either a patient or control, work with the dogs, or by making a donating to our research program.

Johanna Altgelt, Kirk Turner, Michael McCulloch, Kathy O’Brien, and Jett Gulbronsen pose with Tessy and Captain Jennings at the Pine Street Foundation in San Anselmo, California

Tessy, a three-year-old yellow Labrador retriever, sniffs at boxes containing breath samples from women with ovarian cancer and from healthy controls and determines which is which

Tessy closes in on which breath sample was given by a woman with ovarian cancer

A breath sample cartridge inside a weighted training box

Published in “People Magazine” August 17, 2009

At first glance, cancer researcher Michael McCulloch’s lab at the Pine Street Foundation in San Rafael, Calif., looks predictably humdrum — a computer, a few beakers and some vials. And yet, if you look a little closer, there’s something downright peculiar about the place. Most notably, the water bowls, leashes and the roll of paper towels used for sopping up slobber.

For the past 10 years, McCulloch, an acupuncturist by training, has been exploring whether the sensitive nose of his furry, four-legged research subjects can detect cancer. And after hearing accounts of canines that reportedly saved the lives of their human owners by sniffing, pawing and barking at their tumors (long before being diagnosed by a physician), he has been grappling with a thought-provoking theory: If a dog can do that spontaneously, that suggests they can be trained to do it.

The idea isn’t as far-fetched as it sounds, insists Dr. J. Leonard Lichtenfeld, the American Cancer Society’s deputy chief medical officer. “An enormous amount of research is being done to find those proteins present in small quantities in the bloodstream that may signal cancer,” Lichtenfeld tells PEOPLE. “That a dog could smell these is definitely within the realm of possibility.”

McCulloch first became aware of the concept that certain diseases can be detected in a person’s breath from an ancient medical text in the early 1980s while studying acupuncture in Taiwan and mainland China. In 2003, he and his colleagues at the Pine Street Foundation began collecting breath samples from nearly a hundred lung and breast cancer patients. Next, they went to work developing a technique to train a group of dogs to sniff out the samples in much the same way law-enforcement personnel teach canines to use their noses to find narcotics and explosives.

What they learned was truly explosive. It turned out his canine research subjects and their sensitive noses could detect lung cancer 99 percent of the time and had an 88-percent accuracy rate for breast cancer. What McCulloch thinks the dogs are detecting is metabolic waste “from the tumor cells, which is chemically different from normal cells. The waste travels through the bloodstream and is exhaled out through the lungs.”

McCulloch recently began working on a follow-up study funded by the federal government and private donations. Last year, they began collecting breath samples from women recently diagnosed with ovarian cancer, known as a particularly aggressive, fast-growing type of cancer cell rarely detected in its early stages. Once again, McCulloch and his team set out to determine if the dogs could be trained to accurately locate the samples — held in fist-sized plastic tubes — when hidden amongst four other similar tubes containing breath samples from healthy adults.

Although the full results of the study won’t be known until December, so far the canines have displayed uncanny accuracy. Which leads McCulloch to wonder if perhaps some day a woman’s breath sample might prove to be a more accurate and earlier way to detect ovarian cancer than the commonly used blood test or ultrasound.

“What does all this mean?” asks McCulloch. “I think part of the answer is that whenever you see dogs greeting each other out on the street, sniffing each other out, they’re probably asking a very simple question: ‘How’s your health today?’ “

“Can Dogs Detect Cancer?”

Thursday, August 6th, 2009 from 3:30p to 4:30p

LOCATION
Margaret Todd Senior Center
1560 Hill Road, Novato, CA
Click here for a map.

Cost: FREE
Please RSVP to ( 707) 769-8325 or by email.

ABOUT THIS EVENT
Come hear about important, federally funded, ovarian cancer research being conducted in the bay area and learn more about the symptoms and risks of ovarian cancer. A documentary will be shown and there will be Q&A with Pine Street Foundation’s Principal Investigator, Michael McCulloch, LAc, MPH, PhD, who was recently featured in an Oprah Magazine article on this study, “Sniffing Out Cancer”.

Women interested in donating a breath sample for the research study may call (415) 342-0886.

The Women’s Cancer Awareness Group (WCAG) is a non-profit dedicated to creating support programs for cancer survivors, and to increasing awareness of the risk factors and symptoms of gynecologic cancers.

The Pine Street Foundation & The Marin Humane Society present…

“Can Dogs Detect Cancer?”

Tuesday, June 30, 2009 from 12:15 to 1:15pm

LOCATION:
Marin Humane Association
171 Bel Marin Keys Blvd., Novato, CA 94949

Click here for a map.

COST & SEATING:
FREE event.
Priority seating will be given to Marin Humane Staff and Volunteers.
Others please RSVP to (415) 342-0886.

Come hear about important, federally funded, ovarian cancer research being conducted in the bay area and learn more about the symptoms and risks of ovarian cancer. A new video slideshow on this project will be presented and part of a short documentary related to training dogs in the scent detection of various cancers will be shown. There will be Q&A with The Pine Street Foundation’s Principal Investigator, Michael McCulloch, LAc, MPH, PhD. Informational literature on ovarian cancer from The National Ovarian Cancer Coalition will be available.

There will be a LIVE DEMO with the dogs from the trained dog team in this study.

Volunteer Position 1
Light cleaning, set-up, and break-down on Mondays from Noon until 1pm (1 hour). Mopping floors after dogs leave, vacuuming, moving lightweight but bulky dog crates from one room to another, setting up room for breath sample subjects. You will be working with 1 to 2 other experienced volunteers.

Volunteer Position 2
Can you post fliers for us around Marin county for our cancer research study? Fliers are ready now and can be picked up in downtown San Anselmo or mailed to you.

WOMEN NEEDED: Click here for study eligibility.

INTRODUCTION
Is there meaningful information contained within a person’s breath? Could this information lead to early detection of ovarian cancer? In partnership with Touradj Solouki, associate professor of chemistry at the University of Maine, the Pine Street Foundation seeks to answer these questions by using two of the most sensitive and sophisticated scent detection devices on the planet: a type of mass spectrometer and a dog’s nose.

We are thrilled to announce that this project has recently been awarded a federal research grant by the Congressionally Directed Medical Research Program and we’ll be launching this next phase of our groundbreaking canine scent detection work soon.

We will focus specifically on detecting ovarian cancer through analysis of exhaled breath, leading the way towards a truly noninvasive way to diagnose ovarian cancer. A major step forward in this study is that breath analysis will be conducted both with trained dogs here at the Pine Street Foundation as well as with sophisticated analytical chemistry at the laboratories of Dr. Solouki in Maine.

PUBLIC ABSTRACT:
Early Detection of Epithelial Ovarian Cancer Using Exhaled Breath Markers:
GC/FT-ICR Mass Spectrometry and Canine Olfaction

BACKGROUND WORK
Epithelial ovarian cancer is the fifth leading cause of cancer death in women. Early diagnosis is the most important step toward reducing morbidity and mortality from epithelial ovarian cancer (e.g., from less than 10% in late stage cancer to greater than 90% survival rate for early detection). Although some women with early stage ovarian cancer experience symptoms, research has shown that early signs may be misleading. Furthermore, the best current method to test for ovarian cancer, a combination of a blood test called CA-125 and ultrasound of the lower abdomen, is also not an accurate indicator of early-stage disease.

Our preliminary results suggest that human exhaled breath condensate (EBC) may provide an important source of biomarkers for early detection of ovarian cancer. We have explored exhaled breath condensate analysis using a biological method (trained dogs in California labs). In careful double-blinded conditions, we have tested the ability of trained dogs to distinguish ovarian cancer cases from controls using samples of exhaled breath condensate with accuracy of over 97%. In addition, we have acquired preliminary data from chemical methods involving Gas Chromatography/Fourier transform Ion Cyclotron Resonance Mass Spectrometry (GC/FT-ICR MS analyses in Maine labs). Preliminary results strongly suggest that there is a tangible prospect to identify potentially unique biomarkers from exhaled breath condensate for early detection of ovarian cancer. Currently, we hold the GC/MS world record for mass resolving power; this unique ability to distinguish very similar molecules from each other, coupled with the unrivaled capability of FT-ICR MS for accurate mass measurement and identification of minor components in a complex mixture, allows sample “fingerprinting” at the highest level of confidence currently achievable. We believe that these two biological and chemical sensing methods, examined in combination, will allow us to develop a new “breathalyzer” type test for early detection of ovarian cancer from

WHAT WE HOPE TO FIND
We believe that, using our approach, patients with epithelial ovarian cancer can be distinguished from both healthy women and women who have other abdominal disorders, endometriosis or polycystic ovarian syndrome controls. It is anticipated that exhaled breath condensate analysis can predict whether a woman’s ovarian cancer will recur after treatment or become resistant to treatment.

HOW WE PROPOSE TO DO THIS
Our primary aim is to identify exhaled breath condensate biomarker(s) that can be used to distinguish ovarian cancer patients from healthy controls at the molecular level. To accomplish this aim, we will first obtain exhaled breath condensate from both epithelial ovarian cancer cases (between biopsy and initiation of therapy) and healthy controls. We will then analyze the collected samples using sophisticated FT-ICR technology (equipped with electron impact [EI], chemical ionization [CI], and electrospray [ESI] ionization sources), followed by statistical data analysis. Our secondary aim is to train five dogs to discriminate between the exhaled breath condensate of epithelial ovarian cancer patients and healthy controls, using our previously established and published methods. We will use samples of exhaled breath condensate from the same cases and controls, described in the primary aim. Dogs will be trained to indicate the cancer patient samples by sitting directly in front of the cancer sample only, and sniffing but ignoring the samples from healthy controls. Having trained the dogs on a “training set” of epithelial ovarian cancer cases and healthy controls, we will then test this approach with a new set of cases and controls, using a controlled double-blind testing design.

We will apply both of the above methods, chemical analysis and canine scent detection, to distinguish epithelial ovarian cancer patients from controls with polycystic ovarian syndrome and endometriosis.
Finally, in order to test the prognostic capability of these exhaled breath condensate analyses, we will continue to follow epithelial ovarian cancer cases until recurrence, death, or end of the proposed studies.

DESIGN
The proposed project will incorporate a case-control design in which we will compare cases and controls. In order to control for potential confounding by inflammation, which can be associated both with epithelial cancer and other non-malignant diseases such as polycystic ovarian syndrome and endometriosis, we will also collect data on CA-125, level of physical activity, body mass index, and concurrent chronic obstructive pulmonary disease, periodontal disease, rheumatoid arthritis, asthma, rhinitis, diabetes, renal disease, and cardiovascular disease.

RELEVANCE AND INNOVATION
Our team will be the first to use analysis of ECB (both by chemical and biological means), for early detection of epithelial ovarian cancer. The proposed approach is a truly non-invasive diagnostic method. There is a strong short-term potential to extend the proposed procedures to identify biomarkers for early detection of other types of cancers and human diseases. A long-term objective is to exploit our research findings to develop portable devices for early detection of ovarian cancer.

WE WILL NEED YOUR HELP
Although we will receive funds to begin this important research project, your donations towards the following will greatly help:

Research Assistant Salaries: $12,000
Recruitment Coordinator Salaries: $12,000
Research Supplies: $575
Research Equipment: $11,984
Hospital Center Data Coordinators: $30,000
Training Site Costs: $16,800
Ethical Review Board Fees: $5,400
TOTAL: $88,759

Your tax-deductible gift, regardless of size, will really make a difference! Learn more about the ways you can give online by clicking here.

“Can Dogs Detect Cancer?”

Wednesday, June 10, 2009 from 6-7pm

LOCATION
LGBT Center
1800 Market Street @ Octavia
San Francisco, CA
Click here for a map.

Cost: FREE
Free childcare available.
(Please RSVP to (415) 342-0886 if you would like the free childcare.)

ABOUT THIS EVENT
Come hear about important, federally funded, ovarian cancer research being conducted in the bay area and learn more about the symptoms and risks of ovarian cancer. A documentary will be shown and there will be Q&A with Pine Street Foundation’s Principal Investigator, Michael McCulloch, LAc, MPH, PhD. Representatives from the San Francisco chapter of The National Ovarian Cancer Coalition will be available for information and questions.

There will be a LIVE DEMO with one of the dogs from the trained dog team in this study.

A short documentary on recent studies related to training dogs in the scent detection of various cancers will be shown as well as this month’s Oprah Magazine article on this study, “Sniffing Out Cancer”.