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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03656809
Recruitment Status : Completed
First Posted : September 4, 2018
Last Update Posted : August 10, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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.

Condition or disease
Ovarian Cancer

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Study Type : Observational
Actual Enrollment : 125 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Feasibility of Multi-gene Panel Testing at the Time of Diagnosis for Patients With Ovarian Cancer
Actual Study Start Date : October 15, 2015
Actual Primary Completion Date : January 29, 2020
Actual Study Completion Date : January 29, 2020





Primary Outcome Measures :
  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. [ Time Frame: 9 Months ]

Biospecimen Retention:   Samples With DNA
multi-gene panel testing


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Females with ovarian cancer
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
new diagnosis of epithelial ovarian, primary peritoneal, fallopian tube or extra- uterine mullerian cancer.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03656809


Locations
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United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Douglas Levine, MD NYU Langone Health
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03656809    
Other Study ID Numbers: 14-01459
First Posted: September 4, 2018    Key Record Dates
Last Update Posted: August 10, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type