Solid Tumor, AdultNCT03929653
Personalized Therapy of Molecular Tumor Board Participation With the Guidance of Next Generation Sequencing
An observational study of Solid Tumor, Adult, run by Tianjin Medical University Second Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- Personalized therapy model with Molecular Tumor Board and Next Generation Sequencing
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2017to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Medical Unversity Second Hospital
Tianjin, Tianjin Municipality, 300211
About this study
Official title: 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.
Read the 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).
- Conditions
- Solid Tumor, Adult
- Being tested
- Personalized therapy model with Molecular Tumor Board and Next Generation Sequencing
- Keywords
- Next Generation Sequencing, Personalized Therapy, Molecular Tumor Board
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized therapy model with Molecular Tumor Board and Next Generation SequencingOther
This study is to observe this therapy model outcomes
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Personalized therapy model with Molecular Tumor Board and Next Generation Sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to three months
Secondary outcomes (3)
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).
Measured: Up to two years
OS (Overall Survival), calculated from various time points
OS is defined as time from initiation to death of any cause.
Measured: Duration of time from the start of treatment to date of death, assessed up to 2 years
ADR (Adverse Drug Reaction)
Adverse events determined according to CTCAE (version 4.03).
Measured: 30 days after last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start1 Jun 2017
- Primary completion30 Jun 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Second Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haitao Wang, Principal investigator, Tianjin Medical Unversity Second Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03929653
- Sponsor's protocol ID
- MTB-PT
- Status last verified
- Apr 2019
- First submitted
- 24 Apr 2019
- Last updated
- 29 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective and Retrospective Register Study of Personalized Therapy of Molecular Tumor Board Participation With The Guidance of Next Generation Sequencing
- ClinicalTrials.gov ID
- NCT03929653
- Acronym / sponsor ID
- MTB-PT
- Conditions
- Solid Tumor, Adult
- Keywords
- Next Generation Sequencing, Personalized Therapy, Molecular Tumor Board
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Tianjin Medical University Second HospitalUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 29 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced Refractory Solid Tumors | – | Other: Personalized therapy model with Molecular Tumor Board and Next Generation SequencingPatients with advanced refractory solid tumors receive personalized therapy with the guidance of Molecular Tumor Board after the NGS(next generation sequencing). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized therapy model with Molecular Tumor Board and Next Generation SequencingThis study is to observe this therapy model outcomes | Other | Advanced Refractory Solid Tumors |
Primary outcome
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.
3 secondary outcomes
PFS (Progression Free Survival), calculated from various time points
Time frame: 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
ADR (Adverse Drug Reaction)
Time frame: 30 days after last dose.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haitao Wang principal investigator
Tianjin Medical Unversity Second Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Tumor, Adult, run by Tianjin Medical University Second Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR(Objective Response Rate) (time frame: Up to three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2019.