The Effect of Individualized Precision Therapy Programs in Patients With BTC

NCT ID: NCT02943031

Last Updated: 2019-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2020-12-31

Brief Summary

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This is a prospective cohort study. Patients who meet the inclusion criteria will be enrolled in this study. The samples of biliary tract tumors will be collected. Genome sequencing, mini-PDX and PDX will be performed according to the requirement of individualized precision therapy programs. Suitable drugs will be chose according to drug screening results. OS and PFS will be compared with traditional chemotherapy to evaluate the effect of individualized precision therapy programs.

Detailed Description

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In this prospective cohort study, patients who are eligible for inclusion criteria will enroll in the study. After bile duct tumor samples were collected, whole genome sequencing, drug screening ( including Mini-PDX and PDX) will conduct. Suitable drugs will be decided according to the different genomics classification, and then to develop individualized precise treatment programs.

The investigators hope to achieve the following objectives:

① Through the establishment of Individualized Precision Therapy Programs to improve the overall survival of bile duct malignancy (BTC);

② To study the molecular typing of the prognosis of biliary malignancy;

③ To construct a database of BTC gene bank, as well as for drug screening information.

Conditions

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Biliary Tract Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IPTP Group

The IPTP Group will receive the Individualized Precision Therapy Programs. After bile duct tumor samples were collected, whole genome sequencing, drug screening ( including Mini-PDX and PDX) will conduct. Suitable drugs will be decided according to the different genomics classification.OS and PFS will be recorded.

Group Type EXPERIMENTAL

Individualized Precision Therapy Programs

Intervention Type OTHER

After bile duct tumor samples were collected, whole genome sequencing, drug screening ( including Mini-PDX and PDX) will conduct. Suitable drugs will be decided according to the different genomics classification.OS and PFS will be recorded.

Interventions

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Individualized Precision Therapy Programs

After bile duct tumor samples were collected, whole genome sequencing, drug screening ( including Mini-PDX and PDX) will conduct. Suitable drugs will be decided according to the different genomics classification.OS and PFS will be recorded.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Pathological diagnosis of biliary malignancies
* The expected survival time is longer than 3 months
* PKS score\> 60 points
* Willing to take part in the study

Exclusion Criteria

* Can not or refuse to collect tumor samples
* Refused to accept the relevant treatment method
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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JIAN WANG, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Biliary-pancreatic Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Locations

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Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Tao Chen, M.D.

Role: CONTACT

+8613601779874

Facility Contacts

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Tao Chen, MD.

Role: primary

Other Identifiers

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IPTP-BTC

Identifier Type: -

Identifier Source: org_study_id

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