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

Solid Tumor, Adult Clinical Trial

Official title:

Prospective and Retrospective Register Study of Personalized Therapy of Molecular Tumor Board Participation With The Guidance of Next Generation Sequencing

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03929653
• Other study ID #: MTB-PT
• Status: Enrolling by invitation
• Start date: June 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: April 2019
• Source: Tianjin Medical University Second Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: December 31, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Solid Tumor, Adult

Intervention

Other:
• Personalized therapy model with Molecular Tumor Board and Next Generation Sequencing
This study is to observe this therapy model outcomes

Locations

Country	Name	City	State
China	Tianjin Medical Unversity Second Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Second Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PFS (Progression Free Survival), calculated from various time points	Progression-free survival (PFS) is defined as progression free survival of all the evaluable participants who receive targeted drug therapy. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1).	Up to two years
Secondary	OS (Overall Survival), calculated from various time points	OS is defined as time from initiation to death of any cause.	Duration of time from the start of treatment to date of death, assessed up to 2 years
Secondary	ADR (Adverse Drug Reaction)	Adverse events determined according to CTCAE (version 4.03).	30 days after last dose.