Clinical trial · Observational
Clinical Evaluation of Genetron D842V PCR Kit in GIST Patients
NCT05400018CI-TRIAL-00058908completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this trail is to evaluate the performance of Genetron D842V PCR kit in GIST patients using real-time PCR method.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Stromal Tumors | Gastrointestinal Stromal Tumor | ONTOLOGY_EXACT | 0.98 |
| GIST | Gastrointestinal Stromal Tumor | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Ct Value (Ct Values From PCR Reaction)
- timeFrame
- 3 months
- description
- the number of PCR cycles where the amplification signal starts to be observed
Secondary outcomes (4)
- measure
- PPV
- timeFrame
- 3 months
- description
- the ratio of true positive in all positive cases
- measure
- NPV
- timeFrame
- 3 months
- description
- the ratio of true negative in all negative cases
- measure
- Consistency (the Overall Ratio of True Positive and True Negative)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. 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. 2. The sample should have corresponding basic clinical information, including: the patient's unique traceability number, age, gender, pathological diagnosis results, etc. 3. 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. 4. The content of tumor cells meets the requirements of assessment reagents and comparison methods. Exclusion Criteria: 1. 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. 2. Samples that cannot complete the entire testing process. 3. Patients with incomplete sample information.
References
Publications (0)
Data not yet available
No reference posted for this study.