Ovarian Cancer Hemoscope Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02811224

Enrollment

Registered

2016-06-23

Start date

2016-05-31

Completion date

2030-07-31

Last updated

2025-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Neoplasms

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Sensitivity of an assay that detects circulating tumor DNA	3 years

Outcome results