NCT02441140

Brief Summary

This research study is studying a possible test which may help doctors diagnose women with ovarian cancer.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2015

Completed
17 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 12, 2015

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

May 4, 2020

Status Verified

May 1, 2020

Enrollment Period

4.2 years

First QC Date

April 14, 2015

Last Update Submit

May 1, 2020

Conditions

Stage III Ovarian CancerStage IV Ovarian Cancer

Keywords

Stage III Ovarian CancerStage IV Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

  • Number of completed peritoneal fluid collection by culdocentesis after chromopertubation as an assessment of feasibility of peritoneal fluid collection in women with ovarian cancer.

    At the time of surgery

Secondary Outcomes (1)

  • Measure the concentration of cell free DNA in various biologic fluids and compare it to primary tumor DNA.

    At the time of surgery

Study Arms (1)

Culdocentesis

EXPERIMENTAL

* Patients with known or highly likely ovarian cancer (i.e. highly elevated CA-125, ascites, pelvic mass) scheduled for cytoreductive surgery will be identified during preoperative consultation and offered participation in the study. * During Surgery: * Blood Collection * Vaginal Swab * Chromopertubation * Culdocentesis * Tissue Collection

Procedure: CuldocentesisProcedure: Vaginal SwabProcedure: ChromopertubationProcedure: Blood collectionProcedure: Tissue collection

Interventions

CuldocentesisPROCEDURE

A sterile speculum will be placed in the vagina and the cervix identified. The cervix will be elevated using a tenaculum and a spinal needle inserted through the posterior vaginal fornix. Fluid from the posterior cul de sac will be collected

Culdocentesis
Vaginal SwabPROCEDURE

. A sterile speculum will be placed in the vagina and a Pap smear spatula will be used to swab the posterior fornix of the vagina. This swab will then be rinsed in a tube of saline.

Culdocentesis
ChromopertubationPROCEDURE

Chromopertubation is a common gynecologic technique used to test the patency of fallopian tubes during infertility evaluations. Fluid is flushed through the cervix and uterus and out the fallopian tubes.

Culdocentesis
Blood collectionPROCEDURE

Intravenous blood collection will be drawn from an IV

Culdocentesis
Tissue collectionPROCEDURE

As part of the standard surgical procedure for presumed ovarian cancer, the primary tumor will be resected and a sample obtained for evaluation

Culdocentesis

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female
  • Age ≥ 18
  • Able to give informed consent
  • Scheduled for surgery at Brigham and Women's Hospital for known or highly suspected Stage III or IV ovarian cancer (i.e. elevated CA-125 with a pelvic mass, ascites, and carcinomatosis)
  • Post-menopausal or negative urine and/or blood pregnancy test
  • Measurable disease on preoperative imaging

You may not qualify if:

  • Male
  • Age \< 18
  • Unable to give informed consent
  • Not planned for surgical intervention
  • Active malignancy other than ovarian cancer
  • Prior bilateral tubal ligation or hysterectomy (as this would prevent chromopertubation)
  • Known or suspected active pelvic infection
  • Pregnancy
  • No measurable disease or suspected Stage I or II ovarian cancer on preoperative imaging

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

ParacentesisBlood Specimen CollectionTissue Banks

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

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDrainageTherapeuticsPuncturesSurgical Procedures, OperativeInvestigative TechniquesBiological Specimen BanksHealth FacilitiesHealth Care Facilities Workforce and Services

Study Officials

  • Neil Horowitz, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 14, 2015

First Posted

May 12, 2015

Study Start

May 1, 2015

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

May 4, 2020

Record last verified: 2020-05

Locations

US(2)