Feasibility of Multi-gene Panel Testing at the Time of Di... | NCT03656809

Studies
Feasibility of Multi-gene Panel Testing at the Time of Diagnosis for Patients With Ovarian Cancer

NCT03656809

Sponsor

NYU Langone Health

Status

Completed

Last Update Posted

Aug 10, 2020Actual

Enrollment

125Actual

Phase

Not provided

Conditions

Ovarian Cancer

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 15, 2015Actual

Primary Completion Date

Jan 29, 2020Actual

Completion Date

Jan 29, 2020Actual

First Submitted Date

Aug 30, 2018

First Submission Date that Met QC Criteria

Aug 31, 2018

First Posted Date

Sep 4, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 7, 2020

Last Update Posted Date

Aug 10, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

125Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Females with ovarian cancer

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Douglas Levine, MD	NYU Langone Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New York University School of Medicine		New York	New York	10016	United States

Condition Browse Module

MeSH Terms

ID	Term
D010051	Ovarian Neoplasms

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases

Browse Leaves

Not provided

Browse Branches

Not provided