Carcinoma(CAN-IMPACT-IONCT06630273
Canadian Initiative to Measure, Predict and Assess Cancer Treatment Outcomes in Patients Treated With Immuno-Oncotherapeutics
An observational study of Carcinoma, run by Canadian Cancer Trials Group.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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 .
Read the 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.
- Conditions
- Carcinoma
- Medical subject headings
- Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Enrollment | Correlative Collection until time of disease progression of protocol specific IO therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start31 Dec 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CarcinomaStudies of the same condition, open and under way.
- More trials run by Canadian Cancer Trials GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canadian Cancer Trials Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Philippe Bedard, Study chair, University Health Network, Princess Margaret Cancer Centre, Toronto, ON CanadaAnna Spreafico, Study chair, University Health Network, Princess Margaret Cancer Centre, Toronto, ON Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06630273
- Sponsor's protocol ID
- PM2
- Acronym
- (CAN-IMPACT-IO
- Status last verified
- Mar 2026
- First submitted
- 3 Oct 2024
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canadian Initiative to Measure, Predict and Assess Cancer Treatment Outcomes in Patients Treated With Immuno-Oncotherapeutics
- ClinicalTrials.gov ID
- NCT06630273
- Acronym / sponsor ID
- (CAN-IMPACT-IO / PM2
- Conditions
- Carcinoma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Canadian Cancer Trials GroupResearch network
- Study start
- 31 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enrollment | – | –Correlative Collection until time of disease progression of protocol specific IO therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Establishment of a diverse bank of biological samples, stem cell lines, derivatives, and associated information.
Time frame: 3 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Philippe Bedard study chair
University Health Network, Princess Margaret Cancer Centre, Toronto, ON Canada
Anna Spreafico study chair
University Health Network, Princess Margaret Cancer Centre, Toronto, ON Canada
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, run by Canadian Cancer Trials Group.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Janet Dancey (613-533-6430, jdancey@ctg.queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establishment of a diverse bank of biological samples, stem cell lines, derivatives, and associated information. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.