Personalized Therapy of Molecular Tumor Board Participation With the Guidance of Next Generation Sequencing

NCT03929653 | Unknown

• 1 other identifier: MTB-PT
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to evaluate the clinical value of the personalized therapy model with the guidance of Molecular Tumor Board (MTB) after Next Generation Sequencing(NGS), and to track patient outcomes.

Conditions

Solid Tumor, Adult

Keywords

Next Generation Sequencing; Personalized Therapy; Molecular Tumor Board

Outcome Measures

Primary Outcomes (1)

• ORR(Objective Response Rate)

  ORR is the percentage of participants with best overall response of complete response (CR), partial response (PR). Response categories: CR, PR, SD (stable disease), PD (progressive disease) Criteria on which physicians determined therapy response also will be captured by using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 to evaluate.

  Up to three months

Secondary Outcomes (3)

• PFS (Progression Free Survival), calculated from various time points

  Up to two years

• OS (Overall Survival), calculated from various time points

  Duration of time from the start of treatment to date of death, assessed up to 2 years

• ADR (Adverse Drug Reaction)

  30 days after last dose.

Study Arms (1)

Advanced Refractory Solid Tumors

Patients with advanced refractory solid tumors receive personalized therapy with the guidance of Molecular Tumor Board after the NGS(next generation sequencing).

Other: Personalized therapy model with Molecular Tumor Board and Next Generation Sequencing

Interventions

Personalized therapy model with Molecular Tumor Board and Next Generation Sequencing OTHER

This study is to observe this therapy model outcomes

Advanced Refractory Solid Tumors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The objective is to describe in a real-world advanced refractory solid tumors population. First of all, this study will be carried out as a retrospective, observational review of patients who clinically diagnosed as advanced refractory solid tumors received personalized therapy with the guidance of MTB (molecular tumor board) after the NGS (next generation sequencing). Then, the investigators prospective observation personalized therapy plan which the MTB recommends for patients who clinically diagnosed as advanced refractory solid tumors according to the inclusion and exclusion criteria.

You may qualify if:

• Is equal to or greater than 18 years of age.
• Histologic or cytologic confirmation of advanced refractory solid tumors with no standard treatment options, including some patients with advanced disease in reduced general condition (Eastern Cooperative Oncology Group (ECOG) 3 and 4).
• Patients with measurable or evaluable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
• Patients must be able to provide blood samples or tissue samples for NGS (Next Generation Sequencing) testing. The amount of blood and tissue samples should be able to meet the requirements of DNA extraction and quality control.
• Adequate baseline organ system function.
• Patients could receive treatment program from MTB (Molecular Tumor Board).
• Ability to understand and the willingness to provide a written informed consent document.

You may not qualify if:

• According to the investigator' judgment, there are serious, uncontrollable risks to patients' safety, or associated diseases (such as severe diabetes, thyroid disease, infection, spinal cord compression, superior vena cava syndrome, neurological or psychiatric disorders and so on) that affect the patients completion of the study.

Sponsors & Collaborators

• Tianjin Medical University Second Hospital: lead

Study Sites (1)

Tianjin Medical Unversity Second Hospital

Tianjin, Tianjin Municipality, 300211, China

Location

MeSH Terms

Interventions

High-Throughput Nucleotide Sequencing

Intervention Hierarchy (Ancestors)

Sequence Analysis; Genetic Techniques; Investigative Techniques

Study Officials

• Haitao Wang

  Tianjin Medical Unversity Second Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: April 29, 2019
• Study Start: June 1, 2017
• Primary Completion: June 30, 2019
• Study Completion: December 31, 2019
• Last Updated: April 29, 2019

Record last verified: 2019-04

Locations

CN (1)