Renal CarcinomaIMCORNCT05456074
Integrative Molecular Characterization Of MiT Family Translocation Renal Cell Carcinomas (IMCOR)
An observational study of Renal Carcinoma, run by Institut de cancérologie Strasbourg Europe at 4 sites in France.
Trial summary
Microphthalmia transcription factor (MiT) family translocation renal cell carcinomas (TRCC) are rare subtypes of kidney cancers, which often arise in children and young adults. TRCC are characterized by translocations affecting transcription factors: Transcription Factor Binding To Immunoglobulin Heavy Constant Mu… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Renal Carcinoma
- What is being tested?
- Data collection
- How many people
- 600 participants
- Where
- 4 sitesFrance
- Study dates
- 25 Jan 2023to 25 Jan 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with TRCC and other rare kidney tumors
Who may be able to join
- Patients treated for kidney cancer in a clinical center located in France
- For molecular biology study :
- Patients with tumor sample available for genetic and epigenetic analysis. Tumor sample stored in Biological resource facilities and consent given from patient or from parents for the use of biological sample for biomedical research purposes.
Who cannot join
- Objection from patient or parents
Trial locations and contacts
4 sites in 1 country.
France4 sites
Réseau Français de Recherche sur le Cancer du Rein (UroCCR)
Bordeaux
Jean-Christophe Bernhard, MD, PhD
Réseau SIOP, Hôpital Trousseau
Paris
Aurore Coulomb, MD, PhD
Réseau CARARE
Rennes
Nathalie Rioux-Leclercq, MD, PhD
Institut de cancérologie Strasbourg Europe
Strasbourg, 67033
Gabriel MALOUF, MD, PhD
About this study
Microphthalmia transcription factor (MiT) family translocation renal cell carcinomas (TRCC) are rare subtypes of kidney cancers, which often arise in children and young adults. TRCC are characterized by translocations affecting transcription factors: Transcription Factor Binding To Immunoglobulin Heavy Constant Mu Enhancer 3 (TFE3) and Transcription Factor EB (TFEB). Little is known about TRCC molecular heterogeneity, in particular their transcriptomic and epigenetic subtype classification. Clinical behavior of TRCC is varying with age and Tumor, Node, Metastasis (TNM) stage. However, the biological basis of this aggressiveness is poorly understood.
PURPOSE: The primary goal of this study is to decipher specific alterations in aggressive TRCC, defined as cases with metastatic dissemination at diagnosis. To tackle this problem, a retrospective cohort of TRCC cases in children and young adults will be created. We will then perform integrative comprehensive multi-omics analysis of these tumors to identify genetic, epigenetic and immune biomarkers associated with metastatic behavior in a training and validation datasets. Comparison of the multi-omics data will be compared to other type of rare Kidney tumors as well as clear-cell renal cell carcinomas
Read the detailed description
This retrospective cohort study aims to allow tumor collection of TRCC from three different networks: the French research network in renal cancer (UroCCR), the International Society of Paediatric Oncology (SIOP) database and the network for rare renal carcinomas (CARARE). Those samples will be divided in training and validation datasets. We will also collect samples from patients with other rare kidney cancers and clear-cell renal cell carcinomas allowing comparisons of similarity and differences between these tumors.
- Conditions
- Renal Carcinoma
- Being tested
- Data collection
- Keywords
- MiT family translocation renal cell carcinomas, Multiomics, Genetic, Epigenetic
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Retrospective data collection
| Study group | Role | What they receive |
|---|---|---|
| Patients with TRCC | Not described Receives: Other: Data collection | |
| Patients with other rare kidney tumors | Not described Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of genetic alterations associated with TRCC aggressiveness.
Tumor aggressiveness is defined as TRCC cases with metastatic dissemination at diagnosis. Comparison of recurrent genetic aberration identified between metastatic and localized cases.
Measured: at the end of the study (36 months)
Secondary outcomes (3)
Progression free survival (PFS)
Testing for association between molecular tumor features and clinico-pathological patients outcome, PFS, according to the identity of TFE fusion partner
Measured: From renal tumor diagnosis to progression or latest patient news at the end of the study (36 months)
Overall survival (OS)
Testing for association between molecular tumor features and clinico-pathological patients outcome, OS, according to the identity of TFE fusion partner
Measured: From renal tumor diagnosis to death or latest patient news at the end of the study (36 months)6 months)
Contribution of DNA methylation, transcriptome and immune landscape to metastatic potential
Proportion of patients with metastatic disease in each DNA methylation and messenger RNA (mRNA) cluster using hierarchical unsupervised subtype classifications
Measured: at the end of the study (36 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start25 Jan 2023 (estimated)
- Primary completion25 Jan 2026 (estimated)
- Study completion25 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal CarcinomaStudies of the same condition, open and under way.
- 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de cancérologie Strasbourg Europe
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France, Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Gabriel MALOUF, MD, PhD, Principal investigator, Institut de cancérologie Strasbourg Europe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456074
- Sponsor's protocol ID
- 4-2021-001
- Acronym
- IMCOR
- Status last verified
- Nov 2022
- First submitted
- 8 Jul 2022
- Last updated
- 25 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Herrscher H, Boileve A, Lindner V, Barthelemy P, Hutt E, Pierard L, Kurtz JE, Rioux-Leclercq N, Lang H, Malouf GG. [MiT family translocation renal cell carcinomas: Natural history, molecular features and multidisciplinary management]. Bull Cancer. 2020 Feb;107(2):272-280. doi: 10.1016/j.bulcan.2019.11.010. Epub 2020 Feb 7. French.
PubMed 32044098
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Molecular Characterization Of MiT Family Translocation Renal Cell Carcinomas (IMCOR)
- ClinicalTrials.gov ID
- NCT05456074
- Acronym / sponsor ID
- IMCOR / 4-2021-001
- Conditions
- Renal Carcinoma
- Keywords
- MiT family translocation renal cell carcinomas, Multiomics, Genetic, Epigenetic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Institut de cancérologie Strasbourg EuropeUniversity, hospital or other
- Collaborators
- National Cancer Institute, France, Ministry of Health, France
- Study start
- 25 Jan 2023 (estimated)
- Primary completion
- 25 Jan 2026 (estimated)
- Study completion
- 25 Jan 2026 (estimated)
- First posted
- 13 Jul 2022 (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.
Microphthalmia transcription factor (MiT) family translocation renal cell carcinomas (TRCC) are rare subtypes of kidney cancers, which often arise in children and young adults. TRCC are characterized by translocations affecting transcription factors: Transcription Factor Binding To Immunoglobulin Heavy Constant Mu Enhancer 3 (TFE3) and Transcription Factor EB (TFEB). Little is known about TRCC molecular heterogeneity, in particular their transcriptomic and epigenetic subtype classification. Clinical behavior of TRCC is varying with age and Tumor, Node, Metastasis (TNM) stage. However, the biological basis of this aggressiveness is poorly understood.
PURPOSE: The primary goal of this study is to decipher specific alterations in aggressive TRCC, defined as cases with metastatic dissemination at diagnosis. To tackle this problem, a retrospective cohort of TRCC cases in children and young adults will be created. We will then perform integrative comprehensive multi-omics analysis of these tumors to identify genetic, epigenetic and immune biomarkers associated with metastatic behavior in a training and validation datasets. Comparison of the multi-omics data will be compared to other type of rare Kidney tumors as well as clear-cell renal cell carcinomas
Detailed description
This retrospective cohort study aims to allow tumor collection of TRCC from three different networks: the French research network in renal cancer (UroCCR), the International Society of Paediatric Oncology (SIOP) database and the network for rare renal carcinomas (CARARE). Those samples will be divided in training and validation datasets. We will also collect samples from patients with other rare kidney cancers and clear-cell renal cell carcinomas allowing comparisons of similarity and differences between these tumors.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with TRCC | – | Other: Data collection |
| Patients with other rare kidney tumors | – | Other: Data collection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with TRCC and other rare kidney tumors
Key inclusion criteria (3 listed)
- Patients treated for kidney cancer in a clinical center located in France
- Patients with tumor sample available for genetic and epigenetic analysis. Tumor sample stored in Biological resource facilities and consent given from patient or from parents for the use of biological sample for biomedical research purposes.
Key exclusion criteria (1 listed)
- Objection from patient or parents
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 |
|---|---|---|
| Data collectionRetrospective data collection | Other | Patients with TRCC, Patients with other rare kidney tumors |
Primary outcome
Identification of genetic alterations associated with TRCC aggressiveness.
Time frame: at the end of the study (36 months)
Tumor aggressiveness is defined as TRCC cases with metastatic dissemination at diagnosis. Comparison of recurrent genetic aberration identified between metastatic and localized cases.
3 secondary outcomes
Progression free survival (PFS)
Time frame: From renal tumor diagnosis to progression or latest patient news at the end of the study (36 months)
Overall survival (OS)
Time frame: From renal tumor diagnosis to death or latest patient news at the end of the study (36 months)6 months)
Contribution of DNA methylation, transcriptome and immune landscape to metastatic potential
Time frame: at the end of the study (36 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2022.
- Background: PubMed 32044098Herrscher H, Boileve A, Lindner V, Barthelemy P, Hutt E, Pierard L, Kurtz JE, Rioux-Leclercq N, Lang H, Malouf GG. [MiT family translocation renal cell carcinomas: Natural history, molecular features and multidisciplinary management]. Bull Cancer. 2020 Feb;107(2):272-280. doi: 10.1016/j.bulcan.2019.11.010. Epub 2020 Feb 7. French.
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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.
Gabriel MALOUF, MD, PhD principal investigator
Institut de cancérologie Strasbourg Europe
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Carcinoma, run by Institut de cancérologie Strasbourg Europe at 4 sites in France.
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 3 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 25 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Valérie SARTORI (368767223 ext. 33, v.sartori@icans.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of genetic alterations associated with TRCC aggressiveness. (time frame: at the end of the study (36 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05456074, which also lists 1 linked publication.
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 25 Nov 2022.