NCT04946266

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
260

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 30, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

January 5, 2022

Status Verified

December 1, 2021

Enrollment Period

Same day

First QC Date

June 22, 2021

Last Update Submit

December 13, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    36 month

Interventions

Surgical intervention with collection of tissue material

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient with localized kidney tumors

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Les Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Kidney Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • TRICARD Thibault

    les Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2021

First Posted

June 30, 2021

Study Start

December 1, 2021

Primary Completion

December 1, 2021

Study Completion

December 1, 2024

Last Updated

January 5, 2022

Record last verified: 2021-12

Locations