Ovarian Tumor Biopsies to Study Response to Treatments

May 9, 2022 updated by: University Health Network, Toronto

Paired Biopsies to Develop a Cellular Signature

This is a research study to look at differences in tumor tissue from ovarian cancer patients that may help to determine response and resistance to treatments.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Ovarian cancer participants will be asked to have two tumor biopsies during the research study. The first biopsy will be done prior to receiving the participants' assigned treatments as a part of their cancer care and the second biopsy will be done about 3-7 days after starting treatment. Participants who will undergo neoadjuvant treatment and then surgery, will also have their tumor tissue collected during surgery. Participants whose disease worsens while on treatment will also be asked to have an additional, optional tumor biopsy.

The tumor tissue samples will be studied to look at certain proteins and enzymes, including enzymes called kinomes, that may be important in determining response and resistance to the treatment that participants will receive as a part of their cancer care.

Study Type

Observational

Enrollment (Actual)

5

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Patients with histological diagnosis of epithelial ovarian cancer

Description

Inclusion Criteria:

  • Age ≥18 years.
  • Histological diagnosis of epithelial ovarian cancer
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
  • Life expectancy of greater than 3 months
  • Diagnosis of epithelial ovarian cancer undergoing chemotherapy as part of standard care or a clinical trial OR receiving a targeted therapy with a targeted agent
  • Must be agreeable to paired biopsies
  • Must have disease amenable to paired biopsy.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Any contraindication to biopsy
  • Need for anticoagulation that cannot be interrupted

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Epithelial ovarian cancer
  • Whole blood sample collection
  • Up to 3 fresh tumor tissue core biopsies
  • Tumor tissue sample taken from tumor tissue already removed from surgery (if surgery is planned)
Procedure: Blood Draw
CA125 and ctDNA
Procedure: Tumor Tissue Biopsy
Only collected at time of surgery if patient undergoes surgical debulking

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pearson correlation for changes between kinome and CA125
Time Frame: 5 years
5 years
Paired T-test for differences in kinome between responders and non-responders
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2017

Primary Completion (Actual)

October 28, 2021

Study Completion (Actual)

October 28, 2021

Study Registration Dates

First Submitted

October 31, 2016

First Submitted That Met QC Criteria

October 31, 2016

First Posted (Estimate)

November 2, 2016

Study Record Updates

Last Update Posted (Actual)

May 10, 2022

Last Update Submitted That Met QC Criteria

May 9, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KINOME

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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