Clinical trial NCT06630273: Canadian Initiative to Measure, Predict and Assess Cancer Treatment Outcomes in Patients Treated With Immuno-Oncotherapeutics
Official title: Canadian Initiative to Measure, Predict and Assess Cancer Treatment Outcomes in Patients Treated With Immuno-Oncotherapeutics
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Carcinoma
Lead sponsor: Canadian Cancer Trials Group
Sponsor class: NETWORK
First posted: 2024-10-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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 .

Detailed 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.

Eligibility 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, wit 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.

Primary outcomes:
measure: Establishment of a diverse bank of biological samples, stem cell lines, derivatives, and associated information.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Health Network, Princess Margaret Cancer Centre, Toronto, ON Canada
name: Philippe Bedard
role: STUDY_CHAIR
affiliation: University Health Network, Princess Margaret Cancer Centre, Toronto, ON Canada
name: Anna Spreafico
role: STUDY_CHAIR
References: