- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03929653
Personalized Therapy of Molecular Tumor Board Participation With the Guidance of Next Generation Sequencing
April 24, 2019 updated by: Tianjin Medical University Second Hospital
Prospective and Retrospective Register Study of Personalized Therapy of Molecular Tumor Board Participation With The Guidance of Next Generation Sequencing
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tianjin
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Tianjin, Tianjin, China, 300211
- Tianjin Medical Unversity Second Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts 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).
|
This study is to observe this therapy model outcomes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to three months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Up to two years
|
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
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OS is defined as time from initiation to death of any cause.
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Duration of time from the start of treatment to date of death, assessed up to 2 years
|
ADR (Adverse Drug Reaction)
Time Frame: 30 days after last dose.
|
Adverse events determined according to CTCAE (version 4.03).
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30 days after last dose.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 1, 2017
Primary Completion (ANTICIPATED)
June 30, 2019
Study Completion (ANTICIPATED)
December 31, 2019
Study Registration Dates
First Submitted
April 24, 2019
First Submitted That Met QC Criteria
April 24, 2019
First Posted (ACTUAL)
April 29, 2019
Study Record Updates
Last Update Posted (ACTUAL)
April 29, 2019
Last Update Submitted That Met QC Criteria
April 24, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MTB-PT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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