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Ovarian Cancer Hemoscope Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02811224
Recruitment Status : Active, not recruiting
First Posted : June 23, 2016
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Scripps Translational Science Institute

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.

Condition or disease
Ovarian Neoplasms

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Prospective
Study Start Date : May 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Group/Cohort
Ovarian Cancer
Benign Neoplasm



Primary Outcome Measures :
  1. Sensitivity of an assay that detects circulating tumor DNA [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women undergoing surgery as part of the treatment plan for ovarian cancer or a benign gynecological neoplasm.
Criteria

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
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Responsible Party: Scripps Translational Science Institute
ClinicalTrials.gov Identifier: NCT02811224    
Other Study ID Numbers: 15-6644
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders