Ovarian Tumor Biopsies to Study Response to Treatments

Epithelial Ovarian Cancer Clinical Trial

Official title:

Paired Biopsies to Develop a Cellular Signature

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02952521
• Other study ID #: KINOME
• Status: Completed
• Start date: January 25, 2017
• Est. completion date: October 28, 2021

Study information

• Verified date: May 2022
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: October 28, 2021
• Est. primary completion date: October 28, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Epithelial Ovarian Cancer

Intervention

Procedure:
• Blood Draw
CA125 and ctDNA
• Tumor Tissue Biopsy
Only collected at time of surgery if patient undergoes surgical debulking

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

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