Ovarian Cancer Hemoscope Trial

NCT ID: NCT02811224

Last Updated: 2025-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2030-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ovarian Neoplasms

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Ovarian Cancer

No interventions assigned to this group

Benign Neoplasm

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Scripps Translational Science Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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15-6644

Identifier Type: -

Identifier Source: org_study_id

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