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

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT04946266
Collaborator
(none)
260
Enrollment
1
Location
36
Anticipated Duration (Months)
7.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Surgical intervention

Study Design

Study Type:
Observational
Anticipated Enrollment :
260 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prospective Validation of the Prognostic Value of Long Non-coding MFI2-AS1 RNA in Localized Clear Cell Kidney Cancers
Actual Study Start Date :
Dec 1, 2021
Actual Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Expression of MFI2-AS1 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Les Hôpitaux Universitaires de Strasbourg Strasbourg France 67091

Sponsors and Collaborators

  • University Hospital, Strasbourg, France

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT04946266
Other Study ID Numbers:
  • 7349
First Posted:
Jun 30, 2021
Last Update Posted:
Jan 5, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Kidney Neoplasms
Carcinoma, Renal Cell

Study Results

No Results Posted as of Jan 5, 2022