NCT03656809

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2015

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 4, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2020

Completed
Last Updated

August 10, 2020

Status Verified

August 1, 2020

Enrollment Period

4.3 years

First QC Date

August 30, 2018

Last Update Submit

August 7, 2020

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

  • Feasibility of timely routine referral to genetic counseling for all patients with a new diagnosis of epithelial ovarian, primary peritoneal or Fallopian tube cancer.

    9 Months

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales with ovarian cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

new diagnosis of epithelial ovarian, primary peritoneal, fallopian tube or extra- uterine mullerian cancer.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

multi-gene panel testing

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Douglas Levine, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2018

First Posted

September 4, 2018

Study Start

October 15, 2015

Primary Completion

January 29, 2020

Study Completion

January 29, 2020

Last Updated

August 10, 2020

Record last verified: 2020-08

Locations

US(1)