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

Renal Neoplasms Clinical Trial

Official title:

A Multi-site, Open, Perspective Study of Prognostic Value and Benefit From Adjuvant Targeted Therapy of Stage III Clear Cell Renal Cell Carcinoma Based on a CpG-methylation-based Assay

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02688491
• Other study ID #: [2016]015
• Status: Not yet recruiting
• Phase: N/A
• First received: February 18, 2016
• Last updated: February 24, 2016
• Start date: July 2016
• Est. completion date: July 2026

Study information

• Verified date: February 2016
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: Jinhuan Wei, MD
• Phone: +8613580314021
• Email: 342729243[@]qq.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

The investigators' CpG-methylation-based assay contains 5 CpGs: cg00396667（PITX1）, cg18815943 （FOXE3）, cg03890877（TWF2）, cg07611000 （EHBP1L1）and cg14391855（RIN1）. The investigators evaluate the CpG methylation status of surgical specimens using pyrosequencing and calculate their risk score[risk score=(0.0066×PITX1)+(0.0034×FOXE3)－(0.027×TWF2) －(0.018×EHBP1L1)－(0.03×RIN1)], risk score ≥－0.1 as assay-defined high risk status and risk score＜－0.1 as assay-defined low risk status. The investigators randomly assign assay-defined high risk patients of stage III ccRCC into intervention group and control group. The intervention group should receive adjuvant targeted therapy while the control group deserve observation. Primary endpoint is the disease free survival and overall survival.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Neoplasms
• Renal Neoplasms
• Targeted Molecular Therapy

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University	Sun Yat-sen University, Xi’an Jiaotong University College of Medicine, Yantai Yuhuangding Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free survival		From the date of registration to up to10 years	No
Secondary	Overall survival		From the date of registration to up to10 years	No