Autoimmune DiseasesCATCH CANCERNCT06507800
Cancer as a complicATion in reCipients of Autologous Hematopoietic Stem Cell Transplantation for Autoimmune Disease iNdiCation trEated in FRance and Canada?
An observational study of Autoimmune Diseases, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Autologous Hematopoietic Stem Cell Transplantation (AHSCT) is a treatment option for several types of Autoimmune Disease (AD) in patients who remain active despite disease modifying therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Diseases
- What is being tested?
- Observational cohort
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 1 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Adult patients treated bu AHSCT for their autoimmune disease, and followed either in France (MATHEC registry), Calgary (Canada) or Ottawa (Canada)
Who may be able to join
- Aged ≥ 18 years at AHSCT
- Underwent first AHSCT for any AD indication
- Included in the French MATHEC-SFGM-TC registry or the Canadian Ottawa and Calgary databases
- AHSCT between January, 1st, 2000 and December, 31st, 2022
- Informed consent for data registration in the respective original registry/database
Who cannot join
- None
Trial locations and contacts
No sites are listed yet.
About this study
Autologous Hematopoietic Stem Cell Transplantation (AHSCT) is a treatment option for several types of Autoimmune Disease (AD) in patients who remain active despite disease modifying therapies. In this setting, AHSCT was shown to improve overall survival, event free survival and quality of life, with a grade A level evidence for systemic sclerosis (SSc) and multiple sclerosis (MS) patients and its benefit varies according to the AD type and the patient status for the other indications. The number of AHSCT for AD has increased in the past twenty years at each country level in Europe and also in Canada.
Information about cancer after AHSCT for AD is scant, although the AD patients population per se has an increased rate of cancer. This cancer risk can be explained in part by the long term use of immunosuppressive drugs or by other risk factors related to the AD (as in SSc or Crohn) or to the patient. In addition to pretransplant potential risk factors for cancer in AD patients, the use of conditioning regimen, which may vary from low, medium or high immunosuppressive to myeloablative chemotherapy when irradiation is added to the proecedure, may favor the onset of cancer after AHCST. Updated analysis and review of the literature until march 2023 led us to identify only twenty-two cases of cancer or hematological malignancies reported after AHSCT recipients for an AD.
Read more
The incidence of cancer after AHSCT for AD was never considered as a primary endpoint in any previous study.
In this context, the aim of this study is to describe the incidence of cancer after autologous hematopoietic stem cell transplantation (AHSCT) for auto-immune diseases (AD) in the French MATHEC (French scientific network for AD and cellular therapies) and the Ottawa and Calgary patients cohorts from Day 0 until twenty years follow up after AHSCT.
- Conditions
- Autoimmune Diseases
- Being tested
- Observational cohort
- Keywords
- Autoimmune diseases, Hematopoietic Stem Cell Transplantation, Cancer
- Medical subject headings
- Autoimmune Diseases, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational cohortOther
Cancer incidence after AHSCT for an autoimmune indication.
| Study group | Role | What they receive |
|---|---|---|
| MATHEC cohort | French national registry of patients treated by Autologous haematopoietic stem cell transplantation (AHSCT) for their autoimmune disease Receives: Other: Observational cohort | |
| Ottawa cohort | Patients treated by AHSCT for their autoimmune disease and followed in Ottawa Hospital Receives: Other: Observational cohort | |
| Calgary cohort | Patients treated by AHSCT for their autoimmune disease and followed in Calgary Hospital Receives: Other: Observational cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of any cancer after AHSCT for an autoimmune indication
Description of the cancers by site according to the International Classification of Diseases for Oncology, 3rd Edition
Measured: Up to 22 years after AHSCT
Secondary outcomes (5)
Cumulative incidence of cancer by age and sex
Measured: Up to 22 years after AHSCT
Incidence of Non-relapse mortality (NRM)
Measured: Up to 22 years after AHSCT
Incidence of disease relapse/progression
Measured: Up to 22 years after AHSCT
Overall survival (OS)
Measured: Up to 22 years after AHSCT
Causes of death (Causes of death will be classified as related to primary AD disease, the secondary cancer or any other cause).
Measured: Up to 22 years after AHSCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiseasesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507800
- Sponsor's protocol ID
- APHP231300
- Acronym
- CATCH CANCER
- Status last verified
- Jul 2024
- First submitted
- 12 Jul 2024
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer as a complicATion in reCipients of Autologous Hematopoietic Stem Cell Transplantation for Autoimmune Disease iNdiCation trEated in FRance and Canada?
- ClinicalTrials.gov ID
- NCT06507800
- Acronym / sponsor ID
- CATCH CANCER / APHP231300
- Conditions
- Autoimmune Diseases
- Keywords
- Autoimmune diseases, Hematopoietic Stem Cell Transplantation, Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 18 Jul 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.
Autologous Hematopoietic Stem Cell Transplantation (AHSCT) is a treatment option for several types of Autoimmune Disease (AD) in patients who remain active despite disease modifying therapies. In this setting, AHSCT was shown to improve overall survival, event free survival and quality of life, with a grade A level evidence for systemic sclerosis (SSc) and multiple sclerosis (MS) patients and its benefit varies according to the AD type and the patient status for the other indications. The number of AHSCT for AD has increased in the past twenty years at each country level in Europe and also in Canada.
Information about cancer after AHSCT for AD is scant, although the AD patients population per se has an increased rate of cancer. This cancer risk can be explained in part by the long term use of immunosuppressive drugs or by other risk factors related to the AD (as in SSc or Crohn) or to the patient. In addition to pretransplant potential risk factors for cancer in AD patients, the use of conditioning regimen, which may vary from low, medium or high immunosuppressive to myeloablative chemotherapy when irradiation is added to the proecedure, may favor the onset of cancer after AHCST. Updated analysis and review of the literature until march 2023 led us to identify only twenty-two cases of cancer or hematological malignancies reported after AHSCT recipients for an AD.
The incidence of cancer after AHSCT for AD was never considered as a primary endpoint in any previous study.
In this context, the aim of this study is to describe the incidence of cancer after autologous hematopoietic stem cell transplantation (AHSCT) for auto-immune diseases (AD) in the French MATHEC (French scientific network for AD and cellular therapies) and the Ottawa and Calgary patients cohorts from Day 0 until twenty years follow up after AHSCT.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MATHEC cohort | – | Other: Observational cohortFrench national registry of patients treated by Autologous haematopoietic stem cell transplantation (AHSCT) for their autoimmune disease |
| Ottawa cohort | – | Other: Observational cohortPatients treated by AHSCT for their autoimmune disease and followed in Ottawa Hospital |
| Calgary cohort | – | Other: Observational cohortPatients treated by AHSCT for their autoimmune disease and followed in Calgary Hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients treated bu AHSCT for their autoimmune disease, and followed either in France (MATHEC registry), Calgary (Canada) or Ottawa (Canada)
Key inclusion criteria (5 listed)
- Aged ≥ 18 years at AHSCT
- Underwent first AHSCT for any AD indication
- Included in the French MATHEC-SFGM-TC registry or the Canadian Ottawa and Calgary databases
- AHSCT between January, 1st, 2000 and December, 31st, 2022
- Informed consent for data registration in the respective original registry/database
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational cohortCancer incidence after AHSCT for an autoimmune indication. | Other | Calgary cohort, MATHEC cohort, Ottawa cohort |
Primary outcome
Cumulative incidence of any cancer after AHSCT for an autoimmune indication
Time frame: Up to 22 years after AHSCT
Description of the cancers by site according to the International Classification of Diseases for Oncology, 3rd Edition
5 secondary outcomes
Cumulative incidence of cancer by age and sex
Time frame: Up to 22 years after AHSCT
Incidence of Non-relapse mortality (NRM)
Time frame: Up to 22 years after AHSCT
Incidence of disease relapse/progression
Time frame: Up to 22 years after AHSCT
Overall survival (OS)
Time frame: Up to 22 years after AHSCT
Causes of death (Causes of death will be classified as related to primary AD disease, the secondary cancer or any other cause).
Time frame: Up to 22 years after AHSCT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Diseases, run by Assistance Publique - Hôpitaux de Paris.
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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dominique Farge, MD PhD (142499768 ext. +33, dominique.farge-bancel@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of any cancer after AHSCT for an autoimmune indication (time frame: Up to 22 years after AHSCT). 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 18 Jul 2024.