NCT02811224

Brief 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.

Trial Health

83
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
50mo left

Started May 2016

Longer than P75 for all trials

Status
active not recruiting

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 Progress71%
May 2016Jul 2030

Study Start

First participant enrolled

May 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 23, 2016

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
5.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2030

Expected
Last Updated

January 16, 2025

Status Verified

January 1, 2025

Enrollment Period

9.1 years

First QC Date

June 21, 2016

Last Update Submit

January 15, 2025

Conditions

Ovarian Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Sensitivity of an assay that detects circulating tumor DNA

    3 years

Study Arms (2)

Ovarian Cancer

Benign Neoplasm

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 Design

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

Study Record Dates

First Submitted

June 21, 2016

First Posted

June 23, 2016

Study Start

May 1, 2016

Primary Completion

June 1, 2025

Study Completion (Estimated)

July 1, 2030

Last Updated

January 16, 2025

Record last verified: 2025-01