Discovery and Validate of Multi-genetic Biomarkers for Ca... | NCT03030508

Studies
Discovery and Validate of Multi-genetic Biomarkers for Capecitabine in Chinese Colorectal Patients

NCT03030508

Sponsor

Shanghai Changzheng Hospital

Status

Unknown status

Last Update Posted

Jan 25, 2017Estimated

Enrollment

300Estimated

Phase

Not provided

Conditions

Colorectal Cancer
Capecitabine

Interventions

No intervention

Countries

China

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

Jan 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Jan 2019Estimated

Completion Date

Mar 2019Estimated

First Submitted Date

Jan 13, 2017

First Submission Date that Met QC Criteria

Jan 22, 2017

First Posted Date

Jan 25, 2017Estimated

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

Jan 22, 2017

Last Update Posted Date

Jan 25, 2017Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wansheng Chen, Professor, Director of Department of Pharmacy, Shanghai Changzheng HospitalPrincipal Investigator

Lead Sponsor

Shanghai Changzheng HospitalOTHER

Collaborators

Name	Class
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	OTHER
Shanghai Minhang Central Hospital	OTHER
Xuzhou Medical University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

At present, chemotherapy is widely used in the adjuvant treatment of colorectal cancer patients after surgery. Capecitabine is one of the main chemotherapeutic drugs. But the effect is not good enough, the adverse reaction is serious, and the individual differences were significant. The present study shows that these problems are related to the differences in the exposure of capecitabine and its metabolites in different patients. The genetic biomarkers for capecitabine include DRD, MTHFR and TYMS. Mutations in these genes directly affect the expression of metabolic enzymes involved in capecitabine and control the concentration of capecitabine and its metabolites. However, these markers have been obtained through clinical trials in the United States, and their role in predicting the effectiveness or safety of capecitabine and its metabolites has not been validated in Chinese cancer patients.The study was based on a case study of patients with colorectal cancer in China, and capecitabine as the primary postoperative chemotherapy regimen to verify whether the available biomarkers can be used to predict the effectiveness and safety of capecitabine. To clarify the effect of capecitabine on endogenous metabolites, and to study the mechanism of its effect, so as to discover new biomarkers.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group cap		Patients receiving capecitabine chemotherapy after operation	Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other		Group cap

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Adverse Events That Are Related to Treatment	during chemotherapy
Disease-free survival		Three year disease-free survival

Secondary Outcomes

Measure	Description	Time Frame
Three year disease free survival rate		Three year disease free survival rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

more than 18 years old;
patients with colon cancer diagnosed by biopsy (regardless of cancer stage);
received postoperative containing capecitabine chemotherapy;
volunteer to participate in the experiment

Exclusion Criteria:

pregnant and lactating women;
patients with hypersensitivity to fluorouracil or severe metabolic failure;
patients with severe infection;
patients with other cancers other than colorectal cancer within the first five years of colorectal cancer surgery;

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

300 patients with colorectal cancer receiving first chemotherapy after surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wansheng Chen, PhD	Department of medicine of Shanghai Changzheng Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of medicine of Shanghai Changzheng Hospital		Shanghai	Shanghai Municipality	200003	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23781135	Background	Zhang X, Sun B, Lu Z. Evaluation of clinical value of single nucleotide polymorphisms of dihydropyrimidine dehydrogenase gene to predict 5-fluorouracil toxicity in 60 colorectal cancer patients in China. Int J Med Sci. 2013 May 20;10(7):894-902. doi: 10.7150/ijms.5556. Print 2013.
23239314	Background	Li F, Qin X, Chen H, Qiu L, Guo Y, Liu H, Chen G, Song G, Wang X, Li F, Guo S, Wang B, Li Z. Lipid profiling for early diagnosis and progression of colorectal cancer using direct-infusion electrospray ionization Fourier transform ion cyclotron resonance mass spectrometry. Rapid Commun Mass Spectrom. 2013 Jan 15;27(1):24-34. doi: 10.1002/rcm.6420.

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site