Canadian Initiative to Measure, Predict and Assess Cancer Treatment Outcomes in Patients Treated With Immuno-Oncotherapeutics

NCT06630273 | Not Yet Recruiting DMC

• 1 other identifier: PM2
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

The researchers doing this study are interested in doing the following:

• Biomarker research using fresh tumour tissue and normal blood cells, and if required, tumour tissue already collected.
• Bio-banking for use in future research using the collected tumour tissue / blood .

Conditions

Carcinoma

Outcome Measures

Primary Outcomes (1)

• Establishment of a diverse bank of biological samples, stem cell lines, derivatives, and associated information.

  There are no primary endpoints planned for this biobank; endpoints will be specific to research projects that utilize samples/data contained in the biobank. Projects may investigate the biology , etiology, manifestations, progression, risk factors, genetic underpinnings, and treatment of diseases, conditions, and traits.

  3 years

Study Arms (1)

Enrollment

Correlative Collection until time of disease progression of protocol specific IO therapy

Eligibility Criteria

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

Study Population

Patients enrolled in a specified list of immuno-oncology (IO) therapeutic trials with immune checkpoint inhibitors targeting PD1/PDL1 as single agents or in combination currently active in CCTG.

You may qualify if:

• Willingness to submit a blood sample for buffy-coat and at least one tumour biospecimen.
• CAN-PREDICT-IO subgroup:
• Provision of pre-treatment fresh tumour biopsy/resection tumour tissue for patients who will receive IO treatment, in a specified list of IO therapeutic trials currently active in CCTG.
• CAN-PIVOT subgroup:
• Provision of on-treatment or at-progression fresh tumour biopsy/resection tumour tissue for patients who have received IO treatment, in a specified list of IO therapeutic trials currently active in CCTG.
• There are 2 CAN-PIVOT subgroups: Primary resistance is defined as disease progression evident in initial on-treatment imaging or disease stability lasting less than six months. Acquired resistance, on the other hand, manifests as disease progression subsequent to an initial partial or complete response or after a period of disease stability lasting six months or more. Patients on adjuvant treatment, with no evidence of disease (NED) by radiological assessment who develop disease (local recurrence or metastases) after or while on immunotherapy are included.
• Archived formalin fixed paraffin embedded (FFPE) blocks or slides would only be collected from patients who met CAN-IMPACT-IO study criteria and underwent fresh tumour biopsy/resection following consent but had a tumour specimen deemed insufficient for WGTS. The FFPE sample may be used to provide an alternate source of tumour tissue for WGTS in such cases. Where local centre regulations prohibit submission of blocks of tumour tissue, a predetermined number of unstained slides of representative tumour tissue may substitute the tumour block.
• Participant consent for the CAN-IMPACT-IO study must be appropriately obtained in accordance with applicable local and regulatory requirements.

Sponsors & Collaborators

• Canadian Cancer Trials Group: lead

Biospecimen

Retention: SAMPLES WITH DNA

A fresh tumour biopsy with up to 6 cores of tumour

MeSH Terms

Conditions

Carcinoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Philippe Bedard

  University Health Network, Princess Margaret Cancer Centre, Toronto, ON Canada

  STUDY CHAIR

• Anna Spreafico

  University Health Network, Princess Margaret Cancer Centre, Toronto, ON Canada

  STUDY CHAIR

Central Study Contacts

Janet Dancey

CONTACT

613-533-6430; jdancey@ctg.queensu.ca

Study Design

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

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 8, 2024
• Study Start: April 30, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share