Ovarian CancerNCT03656809
Feasibility of Multi-gene Panel Testing at the Time of Diagnosis for Patients With Ovarian Cancer
An observational study of Ovarian Cancer, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to determine the feasibility of routine referral to genetic counseling for all patients with a new diagnosis of epithelial ovarian, primary peritoneal or fallopian tube cancer. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Ovarian Cancer
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2015to 29 Jan 2020
- 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 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: new diagnosis of epithelial ovarian, primary peritoneal, fallopian tube or extra- uterine mullerian cancer.
Who may be able to join
- All subjects must have a new diagnosis of epithelial ovarian, primary peritoneal, fallopian tube or extra- uterine mullerian cancer.
- All subjects must have either undergone primary surgery or be planning neoadjuvant chemotherapy for the treatment of ovarian, primary peritoneal or fallopian tube cancer.
- All subjects must be able to comprehend and communicate in English.
- All subjects must agree to participate.
- A previous diagnosis of cancer is not an exclusion criterion.
- Previous genetic screening is not an exclusion criterion.
Who cannot join
- Patients who do not meet the above inclusion criteria.
- Patients with a diagnosis of a low malignant potential mullerian tumor.
- Patients who are not proficient in English language because the survey aspect of this study is comprised of 4 validated surveys that are only available in English language.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
The purpose of this study is to determine the feasibility of routine referral to genetic counseling for all patients with a new diagnosis of epithelial ovarian, primary peritoneal or fallopian tube cancer.
- Conditions
- Ovarian Cancer
- Medical subject headings
- Ovarian Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of timely routine referral to genetic counseling for all patients with a new diagnosis of epithelial ovarian, primary peritoneal or Fallopian tube cancer.
Measured: 9 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2018
- Study start15 Oct 2015
- Primary completion29 Jan 2020
- Study completion29 Jan 2020
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Douglas Levine, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03656809
- Sponsor's protocol ID
- 14-01459
- Status last verified
- Aug 2020
- First submitted
- 30 Aug 2018
- Last updated
- 10 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Multi-gene Panel Testing at the Time of Diagnosis for Patients With Ovarian Cancer
- ClinicalTrials.gov ID
- NCT03656809
- Acronym / sponsor ID
- 14-01459
- Conditions
- Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 15 Oct 2015 (actual)
- Primary completion
- 29 Jan 2020 (actual)
- Study completion
- 29 Jan 2020 (actual)
- First posted
- 4 Sep 2018 (actual)
- 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 determine the feasibility of routine referral to genetic counseling for all patients with a new diagnosis of epithelial ovarian, primary peritoneal or fallopian tube cancer.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- new diagnosis of epithelial ovarian, primary peritoneal, fallopian tube or extra- uterine mullerian cancer.
Key inclusion criteria (6 listed)
- All subjects must have a new diagnosis of epithelial ovarian, primary peritoneal, fallopian tube or extra- uterine mullerian cancer.
- All subjects must have either undergone primary surgery or be planning neoadjuvant chemotherapy for the treatment of ovarian, primary peritoneal or fallopian tube cancer.
- All subjects must be able to comprehend and communicate in English.
- All subjects must agree to participate.
- A previous diagnosis of cancer is not an exclusion criterion.
Key exclusion criteria (3 listed)
- Patients who do not meet the above inclusion criteria.
- Patients with a diagnosis of a low malignant potential mullerian tumor.
- Patients who are not proficient in English language because the survey aspect of this study is comprised of 4 validated surveys that are only available in English language.
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
Feasibility of timely routine referral to genetic counseling for all patients with a new diagnosis of epithelial ovarian, primary peritoneal or Fallopian tube cancer.
Time frame: 9 Months
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 10 Aug 2020.
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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.
Douglas Levine, MD 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 6 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 10 Aug 2020. 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 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?
Feasibility of timely routine referral to genetic counseling for all patients with a new diagnosis of epithelial ovarian, primary peritoneal or Fallopian tube cancer. (time frame: 9 Months). 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 10 Aug 2020.