Clinical trial NCT03929653: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Solid Tumor, Adult
Keywords: Next Generation Sequencing
Personalized Therapy
Molecular Tumor Board
Lead sponsor: Tianjin Medical University Second Hospital
Sponsor class: OTHER
First posted: 2019-04-29
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
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.

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).

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.

Primary outcomes:
measure: ORR(Objective Response Rate)
timeFrame: Up to three months
Secondary outcomes:
measure: PFS (Progression Free Survival), calculated from various time points
timeFrame: Up to two years
measure: OS (Overall Survival), calculated from various time points
timeFrame: Duration of time from the start of treatment to date of death, assessed up to 2 years
measure: ADR (Adverse Drug Reaction)
timeFrame: 30 days after last dose.
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical Unversity Second Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical Unversity Second Hospital
name: Haitao Wang
role: PRINCIPAL_INVESTIGATOR
References: