Ovarian Tumor Biopsies to Study Response to Treatments

NCT ID: NCT02952521

Last Updated: 2022-05-10

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

COMPLETED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-25

Study Completion Date

2021-10-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Epithelial Ovarian Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

Blood Draw

Intervention Type PROCEDURE

CA125 and ctDNA

Tumor Tissue Biopsy

Intervention Type PROCEDURE

Only collected at time of surgery if patient undergoes surgical debulking

Interventions

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Blood Draw

CA125 and ctDNA

Intervention Type PROCEDURE

Tumor Tissue Biopsy

Only collected at time of surgery if patient undergoes surgical debulking

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amit Oza, M.D.

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Cancer Centre

Locations

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Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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KINOME

Identifier Type: -

Identifier Source: org_study_id

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