A CpG-methylation-based Assay for Stratifying Stage III C... | NCT02688491

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

NCT02688491

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Status

Not yet recruiting

Last Update Posted

Feb 25, 2016Estimated

Enrollment

300Estimated

Phase

Not Applicable

Conditions

Renal Neoplasms
Targeted Molecular Therapy

Interventions

sunitinib

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2016

Primary Completion Date

Jul 2026Estimated

Completion Date

Jul 2026Estimated

First Submitted Date

Feb 18, 2016

First Submission Date that Met QC Criteria

Feb 18, 2016

First Posted Date

Feb 23, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2016

Last Update Posted Date

Feb 25, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jun-Hang Luo, Professor, First Affiliated Hospital, Sun Yat-Sen UniversityPrincipal Investigator

Lead Sponsor

First Affiliated Hospital, Sun Yat-Sen UniversityOTHER

Collaborators

Name	Class
Xi'an Jiaotong University	OTHER
Yantai Yuhuangding Hospital	OTHER
Sun Yat-sen University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A (Intervention group,sunitinib)	Experimental	Beginning 4-12 weeks following radical nephrectomy, patients receive sunitinib malate PO QD for 4 weeks	Drug: sunitinib
B(observation group)	No Intervention	Patients with radical nephrectomy are observed without intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
sunitinib	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Disease free survival		From the date of registration to up to10 years

Secondary Outcomes

Measure	Description	Time Frame
Overall survival		From the date of registration to up to10 years

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jinhuan Wei, MD	Contact	+8613580314021		342729243@qq.com

Overall Officials

Name	Affiliation	Role
Jun-Hang Luo, MD	First Affiliated Hospital, Sun Yat-Sen University	Study Director

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007680	Kidney Neoplasms

Ancestor Terms

ID	Term
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077210	Sunitinib

Ancestor Terms

ID	Term
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided