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

NCT ID: NCT03929653

Last Updated: 2019-04-29

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2019-12-31

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.

Detailed Description

This is a study from the real world. Advanced refractory solid tumors patients with no standard treatment options have a very poor prognosis. In recent years, the application of s Next Generation Sequencing (NGS) has rapidly expanded the breadth and depth of understanding of the molecular mechanism of tumors, laying a foundation for the development of precision medicine for tumors. Researchers can build a molecular phenotype of advanced refractory solid tumors by NGS. Some retrospective study shows that Molecular Tumor Board (MTB) therapy model brings therapeutic hope. So, investigators hope that this therapy model combined with NGS may provide treatment recommendations for advanced refractory solid tumors patients. Those recommendations may include some off-label targeted therapies. This study seeks to evaluate the clinical value of the personalized therapy model with the guidance of MTB after NGS, and to track patient outcomes, including ORR (Objective Response Rate), PFS (Progression Free Survival), OS (Overall Survival) and ADR (Adverse Drug Reaction).

Conditions

Solid Tumor, Adult

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

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).

Personalized therapy model with Molecular Tumor Board and Next Generation Sequencing

Intervention Type: OTHER

This study is to observe this therapy model outcomes

Interventions

Personalized therapy model with Molecular Tumor Board and Next Generation Sequencing

This study is to observe this therapy model outcomes

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Is equal to or greater than 18 years of age.

2. 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).

3. Patients with measurable or evaluable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.

4. 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.

5. Adequate baseline organ system function.

6. Patients could receive treatment program from MTB (Molecular Tumor Board).

7. Ability to understand and the willingness to provide a written informed consent document.

Exclusion Criteria

1.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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University Second Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Haitao Wang

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical Unversity Second Hospital

Locations

Tianjin Medical Unversity Second Hospital

Tianjin, Tianjin Municipality, China

Countries

China

Other Identifiers

MTB-PT

Identifier Type: -

Identifier Source: org_study_id