GISTNCT05400018
Clinical Evaluation of Genetron D842V PCR Kit in GIST Patients
An observational study of GIST and Gastrointestinal Stromal Tumors, run by Genetron Health at 3 sites in China.
Trial summary
The purpose of this trail is to evaluate the performance of Genetron D842V PCR kit in GIST patients using real-time PCR method. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- GIST, Gastrointestinal Stromal Tumors
- How many people
- 1,041 participants
- Where
- 3 sitesChina
- Study dates
- 20 Nov 2020to 25 Feb 2021
- Phase
- Observational
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hospital sample
Who may be able to join
- Paraffin-embedded tissue samples from patients clinically diagnosed with gastrointestinal stromal tumor (GIST), and a small number of other cancers or benign lesions in the gastrointestinal site were included as interference samples.
- The sample should have corresponding basic clinical information, including: the patient's unique traceability number, age, gender, pathological diagnosis results, etc.
- The sample is a formalin-fixed paraffin-embedded gastrointestinal stromal tumor tissue sample, and each sample can provide 5 paraffin sections or 5 paraffin rolls with a thickness of at least 5 µm.
- The content of tumor cells meets the requirements of assessment reagents and comparison methods.
Who cannot join
- The investigator considers that it is not appropriate to continue the clinical trial, such as the samples that are not prepared according to the required steps.
- Samples that cannot complete the entire testing process.
- Patients with incomplete sample information.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Peking University Cancer Hospital
Beijing
Harbin Medical University Cancer Hospital
Harbin
Shanghai Tenth People's Hospital
Shanghai
About this study
The purpose of this trail is to evaluate the performance of Genetron D842V PCR kit in GIST patients using real-time PCR method.
Read the detailed description
This trial follows the principle of synchronous blinding. The enrolled cases are coded, and the enrolled samples are detected with Genetron D842V PCR Kit and Sanger sequencing method. The results were determined independently according to the cutoff values or interpretation requirements provided by each method. The safety and effectiveness of this kit are confirmed and evaluated.
- Conditions
- GIST, Gastrointestinal Stromal Tumors
- Medical subject headings
- Gastrointestinal Stromal Tumors
What is being measured
The primary outcome is the main question the study is designed to answer.
Ct Value (Ct Values From PCR Reaction)
the number of PCR cycles where the amplification signal starts to be observed
Measured: 3 months
Secondary outcomes (4)
PPV
the ratio of true positive in all positive cases
Measured: 3 months
NPV
the ratio of true negative in all negative cases
Measured: 3 months
Consistency (the Overall Ratio of True Positive and True Negative)
The overall consistency ratio of true positive and true negative, i.e. (true positive+true negative)/total number of cases
Measured: 3 months
Kappa coefficient
Kappa coefficient is the consistency analysis of the extent of agreement between the test results of the Genetron D842V PCR kit and sanger sequencing method.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start20 Nov 2020
- Primary completion25 Feb 2021
- Study completion25 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GISTStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,041 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genetron Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peking University Cancer Hospital & Institute, Harbin Medical University, Shanghai 10th People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05400018
- Sponsor's protocol ID
- 20200196
- Status last verified
- Jun 2022
- First submitted
- 23 May 2022
- Last updated
- 6 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No