Canadian Initiative to Measure, Predict and Assess Cancer Treatment Outcomes in Patients Treated With Immuno-Oncotherapeutics ((CAN-IMPACT-IO)

Canadian Cancer Trials Group

Status: Not yet enrolling

Conditions: Carcinoma

Study type: Observational

Funder types: NETWORK

Identifiers

NCT06630273

PM2

Details and patient eligibility

About

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 .

Full description

This study is being done to enable the collection and study of these samples. The results will also look at information on how participants with this type of cancer who received immunotherapy responded to treatment.

Bio-banking is the collection, storage, and use of human body samples and related health information for future research. It provides an important resource for health research locally, across Canada, and around the world. The researchers doing the main study also are interested in storing any left-over tissue and/or blood samples that have not been used up for future research. The research that may be done on these samples in the future is unknown at this time.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 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.

OR

• 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.

Trial design

120 participants in 1 patient group

Enrollment

Description:

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