Kidney CancerMFI2-PREDICTNCT04946266
Prospective Validation of the Prognostic Value of Long Non-coding MFI2-AS1 RNA in Localized Clear Cell Kidney Cancers
An observational study of Kidney Cancer, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
An exploratory analysis of the expression of MFI2-AS1 will be performed at the plasma level with the objective of comparing this expression with tumor tissue. The objective would be to be able to use long non-coding RNA as a biomarker for diagnosis before tissue analysis and for patient follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- Surgical intervention
- Type of treatment
- Surgery or procedure
- How many people
- 260 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2021to Dec 2024
- 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: Patient with localized kidney tumors
Who may be able to join
- Adult patient
- Localized kidney tumors> T1a
- Patient having signed an informed consent
- Patient affiliated to a health insurance plan
- Subject having signed a consent form to participate in research and the constitution of a collection and genetic analyzes
Who cannot join
- Metastatic carcinoma from the outset
- Contraindication to performing a TAP CT with injection of contrast product
- Inability to provide informed information about the subject (subject in an emergency situation, difficulties in understanding, etc.)
- Subject under legal protection
- Subject under tutorship or curatorship
- Pregnancy
- Feeding with milk
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
TRICARD Thibault, +33 03.69.55.10.55, Thibaut.tricard@chru-strasbourg.fr
TRICARD Thibault
About this study
An exploratory analysis of the expression of MFI2-AS1 will be performed at the plasma level with the objective of comparing this expression with tumor tissue. The objective would be to be able to use long non-coding RNA as a biomarker for diagnosis before tissue analysis and for patient follow-up. In addition, correlations will be made between tumor expression of MFI2-AS1 and genetic and immune alterations in tumors in order to better clarify the link between the expression of this long non-coding RNA and the characteristics of the tumor and of the tumor. tumor microenvironment.
- Conditions
- Kidney Cancer
- Being tested
- Surgical intervention
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical interventionProcedure or surgery
Surgical intervention with collection of tissue material
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of MFI2-AS1
To assess the link between tumor expression of MFI2-AS1 in patients with localized clear cell kidney carcinoma and the occurrence of relapse
Measured: 36 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start1 Dec 2021
- Primary completion1 Dec 2021
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- TRICARD Thibault, Principal investigator, les Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04946266
- Sponsor's protocol ID
- 7349
- Acronym
- MFI2-PREDICT
- Status last verified
- Dec 2021
- First submitted
- 22 Jun 2021
- Last updated
- 5 Jan 2022
- 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 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Validation of the Prognostic Value of Long Non-coding MFI2-AS1 RNA in Localized Clear Cell Kidney Cancers
- ClinicalTrials.gov ID
- NCT04946266
- Acronym / sponsor ID
- MFI2-PREDICT / 7349
- Conditions
- Kidney Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- Dec 2024 (estimated)
- First posted
- 30 Jun 2021 (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.
An exploratory analysis of the expression of MFI2-AS1 will be performed at the plasma level with the objective of comparing this expression with tumor tissue. The objective would be to be able to use long non-coding RNA as a biomarker for diagnosis before tissue analysis and for patient follow-up. In addition, correlations will be made between tumor expression of MFI2-AS1 and genetic and immune alterations in tumors in order to better clarify the link between the expression of this long non-coding RNA and the characteristics of the tumor and of the tumor. tumor microenvironment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with localized kidney tumors
Key inclusion criteria (5 listed)
- Adult patient
- Localized kidney tumors> T1a
- Patient having signed an informed consent
- Patient affiliated to a health insurance plan
- Subject having signed a consent form to participate in research and the constitution of a collection and genetic analyzes
Key exclusion criteria (7 listed)
- Metastatic carcinoma from the outset
- Contraindication to performing a TAP CT with injection of contrast product
- Inability to provide informed information about the subject (subject in an emergency situation, difficulties in understanding, etc.)
- Subject under legal protection
- Subject under tutorship or curatorship
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 |
|---|---|---|
| Surgical interventionSurgical intervention with collection of tissue material | Procedure or surgery | – |
Primary outcome
Expression of MFI2-AS1
Time frame: 36 month
To assess the link between tumor expression of MFI2-AS1 in patients with localized clear cell kidney carcinoma and the occurrence of relapse
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Kidney Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
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.
TRICARD Thibault principal investigator
les Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Cancer, run by University Hospital, Strasbourg, France at 1 site 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 5 inclusion and 7 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 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 TRICARD Thibault (+ 33 3.69.55.10.55, Thibaut.tricard@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression of MFI2-AS1 (time frame: 36 month). 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 5 Jan 2022.