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

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ClinicalTrials.gov Identifier: NCT03929653
Recruitment Status : Enrolling by invitation
First Posted : April 29, 2019
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Tianjin Medical University Second Hospital

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).

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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

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




Primary Outcome Measures :
  1. 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 :
  1. 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).

  2. 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.

  3. ADR (Adverse Drug Reaction) [ Time Frame: 30 days after last dose. ]
    Adverse events determined according to CTCAE (version 4.03).



Information from the National Library of Medicine

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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:

  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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929653


Locations
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China, Tianjin
Tianjin Medical Unversity Second Hospital
Tianjin, Tianjin, China, 300211
Sponsors and Collaborators
Tianjin Medical University Second Hospital
Investigators
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Principal Investigator: Haitao Wang Tianjin Medical Unversity Second Hospital

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Responsible Party: Tianjin Medical University Second Hospital
ClinicalTrials.gov Identifier: NCT03929653     History of Changes
Other Study ID Numbers: MTB-PT
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tianjin Medical University Second Hospital:
Next Generation Sequencing
Personalized Therapy
Molecular Tumor Board