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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02811224
Other study ID # 15-6644
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 2016
Est. completion date July 2025

Study information

Verified date March 2021
Source Scripps Translational Science Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 50
Est. completion date July 2025
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Scripps Translational Science Institute

Outcome

Type Measure Description Time frame Safety issue
Primary Sensitivity of an assay that detects circulating tumor DNA 3 years
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