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A CpG-methylation-based Assay for Stratifying Stage III Clear Cell Renal Cell Carcinoma of Receiving Adjuvant Treatment

NCT02688491 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2016-02-25

No results posted yet for this study

Summary

Whether patients with stage III clear cell renal cell carcinoma(ccRCC) should receive adjuvant targeted therapy or not is still on debate. The investigators invented a assay consisting of 5 CpGs: cg00396667（PITX1）, cg18815943 （FOXE3）, cg03890877（TWF2）, cg07611000 （EHBP1L1）and cg14391855（RIN1）that was successfully categorise patients with stage III clear cell renal cell carcinoma into high-risk and low-risk groups with Harzard Ratio(HR) of 4.93. Here the investigators randomly assign assay-defined high risk patients of locally advanced ccRCC into adjuvant targeted therapy group and observation group.Disease free survival and overall survival are the end points of observation.

Conditions

  • Renal Neoplasms
  • Targeted Molecular Therapy

Interventions

DRUG

sunitinib

The investigators randomly assign assay-defined high risk patients of stageIII ccRCC into intervention group and observation group. The intervention group should receive adjuvant targeted therapy while the control group deserve observation.

Sponsors & Collaborators

  • Xi'an Jiaotong University

    collaborator OTHER

  • Yantai Yuhuangding Hospital

    collaborator OTHER

  • Sun Yat-sen University

    collaborator OTHER

  • First Affiliated Hospital, Sun Yat-Sen University

    lead OTHER

Principal Investigators

  • Jun-Hang Luo, MD · First Affiliated Hospital, Sun Yat-Sen University

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2026-07-31
Completion
2026-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02688491 on ClinicalTrials.gov