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出境医 / 临床实验 / Personalized Therapy of Molecular Tumor Board Participation With the Guidance of Next Generation Sequencing
Personalized Therapy of Molecular Tumor Board Participation With the Guidance of Next Generation Sequencing
Study Description
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Solid Tumor, Adult | Other: Personalized therapy model with Molecular Tumor Board and Next Generation Sequencing |
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).
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 500 participants |
| Observational Model: | Other |
| Time Perspective: | Other |
| Official Title: | Prospective and Retrospective Register Study of Personalized Therapy of Molecular Tumor Board Participation With The Guidance of Next Generation Sequencing |
| Actual Study Start Date : | June 1, 2017 |
| Estimated Primary Completion Date : | June 30, 2019 |
| Estimated Study Completion Date : | December 31, 2019 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
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
This study is to observe this therapy model outcomes
|
Outcome Measures
Primary Outcome Measures :
- ORR(Objective Response Rate) [ Time Frame: Up to three months ]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.
Secondary Outcome Measures :
- PFS (Progression Free Survival), calculated from various time points [ Time Frame: Up to two years ]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).
- OS (Overall Survival), calculated from various time points [ Time Frame: Duration of time from the start of treatment to date of death, assessed up to 2 years ]OS is defined as time from initiation to death of any cause.
- ADR (Adverse Drug Reaction) [ Time Frame: 30 days after last dose. ]Adverse events determined according to CTCAE (version 4.03).
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| 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.
Criteria
Inclusion Criteria:
- 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.
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.
Contacts and Locations
Locations
| China, Tianjin | |
| Tianjin Medical Unversity Second Hospital | |
| Tianjin, Tianjin, China, 300211 | |
Sponsors and Collaborators
Tianjin Medical University Second Hospital
Investigators
| Principal Investigator: | Haitao Wang | Tianjin Medical Unversity Second Hospital |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | April 24, 2019 | ||||
| First Posted Date | April 29, 2019 | ||||
| Last Update Posted Date | April 29, 2019 | ||||
| Actual Study Start Date | June 1, 2017 | ||||
| Estimated Primary Completion Date | June 30, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
ORR(Objective Response Rate) [ Time Frame: Up to three months ] 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.
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures |
|
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Personalized Therapy of Molecular Tumor Board Participation With the Guidance of Next Generation Sequencing | ||||
| Official Title | Prospective and Retrospective Register Study of Personalized Therapy of Molecular Tumor Board Participation With The Guidance of Next Generation Sequencing | ||||
| 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). | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Other Time Perspective: Other |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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. | ||||
| Condition | 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
|
||||
| Study Groups/Cohorts | 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).
Intervention: Other: Personalized therapy model with Molecular Tumor Board and Next Generation Sequencing
|
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Unknown status | ||||
| Estimated Enrollment |
500 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | December 31, 2019 | ||||
| Estimated Primary Completion Date | June 30, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
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. |
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03929653 | ||||
| Other Study ID Numbers | MTB-PT | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Tianjin Medical University Second Hospital | ||||
| Study Sponsor | Tianjin Medical University Second Hospital | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Tianjin Medical University Second Hospital | ||||
| Verification Date | April 2019 | ||||
