Prospective Validation of the Prognostic Value of Long Non-coding MFI2-AS1 RNA in Localized Clear Cell Kidney Cancers (MFI2-PREDICT)

December 13, 2021 updated by: University Hospital, Strasbourg, France
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

260

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Les Hôpitaux Universitaires de Strasbourg
        • Contact:
        • Principal Investigator:
          • TRICARD Thibault
        • Sub-Investigator:
          • MALOUF Gabriel
        • Sub-Investigator:
          • LANG Hervé
        • Sub-Investigator:
          • BERGERAT Sébastien
        • Sub-Investigator:
          • STORY Fleur
        • Sub-Investigator:
          • MUNIER Pierre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patient with localized kidney tumors

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
36 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: TRICARD Thibault, Les Hôpitaux Universitaires de Strasbourg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Actual)

December 1, 2021

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

June 22, 2021

First Submitted That Met QC Criteria

June 22, 2021

First Posted (Actual)

June 30, 2021

Study Record Updates

Last Update Posted (Actual)

January 5, 2022

Last Update Submitted That Met QC Criteria

December 13, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7349

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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