Ovarian CancerNCT00531778
NYU Ovarian Cancer Early Detection Program Blood and Genetics
An observational study of Ovarian Cancer, run by NYU Langone Health at 1 site in United States.
Trial summary
Improving current strategies for detection of early stage disease can impact favorably on long-term survival of women with ovarian cancer. To reduce the morbidity and mortality of ovarian cancer, screening for this disease must detect early stage disease rather than advanced stage disease. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- How many people
- 890 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Nov 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: women noted to be at increased risk for developing ovarian cancer
Who may be able to join
- Women enrolled in the NYU Ovarian Cancer Early Detection Program have at least one of the following risk factors:
- A personal history of breast cancer
- One or more first degree relatives (mother, sister, daughter) with ovarian cancer
- Multiple family members with either breast and/or ovarian cancer
- A personal history of a positive BRCA1 or BRCA2 genetic test result
- A close relative with a positive BRCA1 or BRCA2 genetic test result
Show all 12Show fewer
- A personal history of colon or endometrial cancer with at least two relatives with a Lynch/HNPCC-associated cancer (colorectal, endometrial, small bowel, ureter, or renal pelvis cancer)
- Synchronous or metachronous endometrial and colorectal cancer
- A personal history of a mismatch repair gene mutation (MLH1, MSH2, MSH6 or PMS2)
- A close relative with a mismatch repair gene mutation (MLH1, MSH2, MSH6 or PMS2)
- A personal history of colorectal or endometrial cancer with a mismatch repair defect (ie. Microsatellite instability (MSI) or immunohistochemical loss of expression of MLH1, MSH2, MSH6, or PMS2)
- The use of fertility drugs for more than one year
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
NYUCancer Institute Clinical Cancer Center
New York, New York, 10016
About this study
Improving current strategies for detection of early stage disease can impact favorably on long-term survival of women with ovarian cancer. To reduce the morbidity and mortality of ovarian cancer, screening for this disease must detect early stage disease rather than advanced stage disease. Thus the challenge for the future is to identify and develop highly sensitive and specific tumor markers that can be applied to population-based screening for the early detection of ovarian cancer.
Read the detailed description
The aim of NYU Ovarian Cancer Early Detection Program is to establish an effective, early detection program employing state-of-the-art science and technology in collaboration with other nationally recognized clinicians and scientists.
This proposed research study will foster collaboration between clinicians and scientists that will facilitate the rapid identification of a set of molecular, biochemical, functional, and genetic markers which can be employed to effectively detect and manage ovarian cancer and other gynecological malignancies.
- Conditions
- Ovarian Cancer
- Keywords
- Women with increased risk for developing ovarian cancer, early detection, biomarker for ovarian cancer
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NYU OCEDP Population | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
identification and development of highly sensitive and specific tumor markers for ovarian cancer
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2007 (estimated)
- Study startJun 2004
- Study completionNov 2010
Why it stopped: insufficient funding and resource
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 890 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Investigators
- Bhavana Pothuri, M.D., Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00531778
- Sponsor's protocol ID
- NYU 04-30 H11938
- Status last verified
- Jan 2011
- First submitted
- 18 Sep 2007
- Last updated
- 11 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NYU Ovarian Cancer Early Detection Program Blood and Genetics
- ClinicalTrials.gov ID
- NCT00531778
- Acronym / sponsor ID
- NYU 04-30 H11938
- Conditions
- Ovarian Cancer
- Keywords
- Women with increased risk for developing ovarian cancer, early detection, biomarker for ovarian cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: insufficient funding and resource
- Enrolment
- 890 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jun 2004
- Study completion
- Nov 2010 (actual)
- First posted
- 19 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Improving current strategies for detection of early stage disease can impact favorably on long-term survival of women with ovarian cancer. To reduce the morbidity and mortality of ovarian cancer, screening for this disease must detect early stage disease rather than advanced stage disease. Thus the challenge for the future is to identify and develop highly sensitive and specific tumor markers that can be applied to population-based screening for the early detection of ovarian cancer.
Detailed description
The aim of NYU Ovarian Cancer Early Detection Program is to establish an effective, early detection program employing state-of-the-art science and technology in collaboration with other nationally recognized clinicians and scientists.
This proposed research study will foster collaboration between clinicians and scientists that will facilitate the rapid identification of a set of molecular, biochemical, functional, and genetic markers which can be employed to effectively detect and manage ovarian cancer and other gynecological malignancies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NYU OCEDP Population | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- women noted to be at increased risk for developing ovarian cancer
Key inclusion criteria (12 listed)
- Women enrolled in the NYU Ovarian Cancer Early Detection Program have at least one of the following risk factors:
- A personal history of breast cancer
- One or more first degree relatives (mother, sister, daughter) with ovarian cancer
- Multiple family members with either breast and/or ovarian cancer
- A personal history of a positive BRCA1 or BRCA2 genetic test result
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
identification and development of highly sensitive and specific tumor markers for ovarian cancer
Time frame: 5 years
Results and safety
The study was stopped early (reason given: insufficient funding and resource). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bhavana Pothuri, M.D. principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: insufficient funding and resource). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
identification and development of highly sensitive and specific tumor markers for ovarian cancer (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2011.