Overview

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

Status:
Not yet recruiting
Trial end date:
2026-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
First Affiliated Hospital, Sun Yat-Sen University
Collaborators:
Health Science Center of Xi'an Jiaotong University
Health Science Center of Xi’an Jiaotong University
Sun Yat-sen University
Yantai Yuhuangding Hospital
Treatments:
Sunitinib
Criteria
Inclusion Criteria:

- The informed consent has been obtained from the patient.

- With confirmed diagnosis of stage III clear cell renal cell carcinoma

- With moderate/good ECOG health rating (PS): 0-1 score.

- The patient receive no anti-cancer treatment before primary surgery.

- The patient receive radical operation for renal cancer with negative margin.

Exclusion Criteria:

- With severe comorbidities, such as cardiovascular disease, chronic obstructive
pulmonary disease, diabetes mellitus, and chronic renal dysfunction.

- With bad compliance or contraindication to enrollment.

- Pregnant woman or lactating woman.

- With contraindication to receive adjuvant targeted therapy.