Ovarian CancerNCT00849199
Cancer Screening and Prevention Program for High Risk Women
An observational study of Ovarian Cancer and Breast Cancer, run by NYU Langone Health at 3 sites in United States.
Trial summary
The purpose of this study is to collect information from a large group of women who may have a greater chance to develop cancer because of their own personal history of cancer or because of their family history of cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Breast Cancer
- How many people
- 1,452 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2001to Jan 2018
- 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: Primarily disadvantaged women who have a family history of breast and or ovarian cancer or who have had a personal history of breast and or ovarian cancer or who themselves or a relative have positive genetic markers for breast or ovarian cancer.
Who may be able to join
- Female or male over the age of 18.
- Patients who have a family history of breast and or ovarian cancer.
- Patients who have had a personal history of breast and or ovarian cancer or who themselves or a relative have positive genetic markers for breast or ovarian cancer.
- Patients who seek medical screening and risk assessment for perceived increased risk of breast or ovarian cancer.
Who cannot join
- Women with psychiatric, psychological or other conditions which prevent fully informed consent.
- Patients seeking medical attention not related to the purposes of this protocol, (e.g. those seeking treatment of a known cancer).
- Women with a history of any medical condition, which places the subject at risk, related to the need for donating blood for research purposes, (e.g., chronic infectious diseases, severe anemia, or hemophilia).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Bellevue Hospital
New York, New York, 10016
NYU Cancer Center
New York, New York, 10016
NYU Tisch Hospital
New York, New York, 10016
About this study
The purpose of this study is to collect information from a large group of women who may have a greater chance to develop cancer because of their own personal history of cancer or because of their family history of cancer.
Read the detailed description
The objectives of this study are to be a resource of information on women's cancers, including the availability of a genetics counselor for women at risk for hereditary cancer, especially ovarian cancer; to provide referrals for diagnostic tests and appropriate clinics involved in early detection of cancer; to provide access to clinical trials and investigational screening methods in cancer early detection and prevention, whenever applicable; to provide women with educational materials; to develop a database of information compiled from the questionnaires and clinics for use in future studies; to create a registry of family history data from women of diverse racial and ethnic backgrounds who attend our clinic, i.e. who perceive themselves to be at increased risk of breast or gynecologic cancers.Women that participate in the study will be interviewed and asked to fill out a questionnaire. An assessment will then be made based on their information. Based on this assessment, women will be referred to the appropriate clinic or for diagnostic testing or provided with information regarding available protocol studies.
- Conditions
- Ovarian Cancer, Breast Cancer
- Keywords
- screening, early detection, prevention, cancer, high risk, ovarian cancer, breast cancer
- Medical subject headings
- Ovarian Neoplasms, Breast Neoplasms, 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 |
|---|---|---|
| High risk of breast or ovarian cancer | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To create a registry for women at high risk of breast or ovarian cancer
Measured: 15 years
Secondary outcomes (1)
To provide genetic counseling, referrals for diagnostic tests and to appropriate clinics to promote the early detection of cancer; to seek and develop research protocols of early detection and treatment
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2009 (estimated)
- Study startJul 2001
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 1,452 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Lynne Cohen Foundation for Ovarian Cancer Research
- Responsible party
- Sponsor
- Investigators
- Franco Muggia, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00849199
- Sponsor's protocol ID
- 9541
- Other IDs
- NYU H#9541
- Status last verified
- May 2020
- First submitted
- 20 Feb 2009
- Last updated
- 6 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Smith J, Baer L, Blank S, Dilawari A, Carapetyan K, Alvear M, Utate M, Curtin J, Muggia F. A screening and prevention programme serving an ethnically diverse population of women at high risk of developing breast and/or ovarian cancer. Ecancermedicalscience. 2009;3:123. doi: 10.3332/ecancer.2008.123. Epub 2009 Mar 16.
PubMed 22275995
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Screening and Prevention Program for High Risk Women
- ClinicalTrials.gov ID
- NCT00849199
- Acronym / sponsor ID
- 9541
- Conditions
- Ovarian Cancer, Breast Cancer
- Keywords
- screening, early detection, prevention, cancer, high risk, ovarian cancer, breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,452 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Lynne Cohen Foundation for Ovarian Cancer Research
- Study start
- Jul 2001
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 23 Feb 2009 (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.
The purpose of this study is to collect information from a large group of women who may have a greater chance to develop cancer because of their own personal history of cancer or because of their family history of cancer.
Detailed description
The objectives of this study are to be a resource of information on women's cancers, including the availability of a genetics counselor for women at risk for hereditary cancer, especially ovarian cancer; to provide referrals for diagnostic tests and appropriate clinics involved in early detection of cancer; to provide access to clinical trials and investigational screening methods in cancer early detection and prevention, whenever applicable; to provide women with educational materials; to develop a database of information compiled from the questionnaires and clinics for use in future studies; to create a registry of family history data from women of diverse racial and ethnic backgrounds who attend our clinic, i.e. who perceive themselves to be at increased risk of breast or gynecologic cancers.Women that participate in the study will be interviewed and asked to fill out a questionnaire. An assessment will then be made based on their information. Based on this assessment, women will be referred to the appropriate clinic or for diagnostic testing or provided with information regarding available protocol studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High risk of breast or ovarian cancer | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primarily disadvantaged women who have a family history of breast and or ovarian cancer or who have had a personal history of breast and or ovarian cancer or who themselves or a relative have positive genetic markers for breast or ovarian cancer.
Key inclusion criteria (4 listed)
- Female or male over the age of 18.
- Patients who have a family history of breast and or ovarian cancer.
- Patients who have had a personal history of breast and or ovarian cancer or who themselves or a relative have positive genetic markers for breast or ovarian cancer.
- Patients who seek medical screening and risk assessment for perceived increased risk of breast or ovarian cancer.
Key exclusion criteria (3 listed)
- Women with psychiatric, psychological or other conditions which prevent fully informed consent.
- Patients seeking medical attention not related to the purposes of this protocol, (e.g. those seeking treatment of a known cancer).
- Women with a history of any medical condition, which places the subject at risk, related to the need for donating blood for research purposes, (e.g., chronic infectious diseases, severe anemia, or hemophilia).
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
To create a registry for women at high risk of breast or ovarian cancer
Time frame: 15 years
1 secondary outcome
To provide genetic counseling, referrals for diagnostic tests and to appropriate clinics to promote the early detection of cancer; to seek and develop research protocols of early detection and treatment
Time frame: 15 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2020.
- Results publication: PubMed 22275995Smith J, Baer L, Blank S, Dilawari A, Carapetyan K, Alvear M, Utate M, Curtin J, Muggia F. A screening and prevention programme serving an ethnically diverse population of women at high risk of developing breast and/or ovarian cancer. Ecancermedicalscience. 2009;3:123. doi: 10.3332/ecancer.2008.123. Epub 2009 Mar 16.
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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.
Franco Muggia, MD principal investigator
NYU Langone Health
3 sites 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 and Breast Cancer, run by NYU Langone Health at 3 sites 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 6 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To create a registry for women at high risk of breast or ovarian cancer (time frame: 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00849199, which also lists 1 linked publication.
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 6 May 2020.