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

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ClinicalTrials.gov Identifier: NCT02688491
Recruitment Status : Not yet recruiting
First Posted : February 23, 2016
Last Update Posted : February 25, 2016
Sponsor:
Collaborators:
Health Science Center of Xi’an Jiaotong University
Yantai Yuhuangding Hospital
Sun Yat-sen University
Information provided by (Responsible Party):
Jun-Hang Luo, First Affiliated Hospital, Sun Yat-Sen University

Brief 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.

Condition or disease Intervention/treatment Phase
Renal Neoplasms Targeted Molecular Therapy Drug: sunitinib Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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
Study Start Date : July 2016
Estimated Primary Completion Date : July 2026
Estimated Study Completion Date : July 2026


Arm Intervention/treatment
Experimental: A (Intervention group,sunitinib)
Beginning 4-12 weeks following radical nephrectomy, patients receive sunitinib malate PO QD for 4 weeks
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.

No Intervention: B(observation group)
Patients with radical nephrectomy are observed without intervention



Primary Outcome Measures :
  1. Disease free survival [ Time Frame: From the date of registration to up to10 years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: From the date of registration to up to10 years ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02688491


Contacts
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Contact: Jinhuan Wei, MD +8613580314021 342729243@qq.com

Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University
Health Science Center of Xi’an Jiaotong University
Yantai Yuhuangding Hospital
Sun Yat-sen University
Investigators
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Study Director: Jun-Hang Luo, MD First Affiliated Hospital, Sun Yat-Sen University

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Responsible Party: Jun-Hang Luo, Professor, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02688491     History of Changes
Other Study ID Numbers: [2016]015
First Posted: February 23, 2016    Key Record Dates
Last Update Posted: February 25, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Protein Kinase Inhibitors
Carcinoma, Renal Cell
Kidney Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action