Ovarian Tumor Biopsies to Study Response to Treatments

Paired Biopsies to Develop a Cellular Signature

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02952521

Enrollment

Registered

2016-11-02

Start date

2017-01-25

Completion date

2021-10-28

Last updated

2022-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epithelial Ovarian Cancer

Brief summary

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

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.

Interventions

PROCEDURETumor Tissue Biopsy

Only collected at time of surgery if patient undergoes surgical debulking

PROCEDUREBlood Draw

CA125 and ctDNA

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026