Ovarian Tumor Biopsies to Study Response to Treatments

NCT02952521 | Completed DMC

• 1 other identifier: KINOME
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Epithelial Ovarian Cancer

Outcome Measures

Primary Outcomes (2)

• Pearson correlation for changes between kinome and CA125

  5 years

• Paired T-test for differences in kinome between responders and non-responders

  5 years

Study Arms (1)

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; Procedure: Tumor Tissue Biopsy

Interventions

Blood Draw PROCEDURE

CA125 and ctDNA

Epithelial ovarian cancer

Tumor Tissue Biopsy PROCEDURE

Only collected at time of surgery if patient undergoes surgical debulking

Epithelial ovarian cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with histological diagnosis of epithelial ovarian cancer

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

* Whole blood samples * Tumor tissue samples

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Amit Oza, M.D.

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2016
• First Posted: November 2, 2016
• Study Start: January 25, 2017
• Primary Completion: October 28, 2021
• Study Completion: October 28, 2021
• Last Updated: May 10, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)