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.