Ovarian Cancer Hemoscope Trial

March 16, 2021 updated by: Scripps Translational Science Institute
This is a prospective, gold standard observational trial designed to enroll consecutive, consenting ovarian cancer patients for the purpose of determining sensitivity of an assay that detects circulating tumor DNA. This observational pilot trial will also be used to examine the genetic variants/mutations present in the tumor tissue DNA.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

50

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women undergoing surgery as part of the treatment plan for ovarian cancer or a benign gynecological neoplasm.

Description

Inclusion Criteria:

Case Group

  • Patients with ovarian cancer undergoing surgery (all stages)
  • Over 18 years old

Control Group

  • Patients with a benign gynecological condition undergoing surgery
  • Over 18 years old

Exclusion Criteria:

  • Previous cancer diagnosis (all)
  • Radiation therapy before surgical treatment
  • Bone marrow transplant
  • Chemotherapy before surgical treatment
  • Invasive procedure resulting in damage to tissue (e.g., surgery, biopsy, thermal ablation) in the 7 days prior to baseline (pre-surgical) blood collection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Ovarian Cancer
Benign Neoplasm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensitivity of an assay that detects circulating tumor DNA
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scripps Translational Science Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

July 1, 2025

Study Registration Dates

First Submitted

June 21, 2016

First Submitted That Met QC Criteria

June 22, 2016

First Posted (Estimate)

June 23, 2016

Study Record Updates

Last Update Posted (Actual)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 16, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-6644

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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