NCT05400018

Brief Summary

The purpose of this trail is to evaluate the performance of Genetron D842V PCR kit in GIST patients using real-time PCR method.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,041

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 23, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 1, 2022

Completed
Last Updated

June 6, 2022

Status Verified

June 1, 2022

Enrollment Period

3 months

First QC Date

May 23, 2022

Last Update Submit

June 1, 2022

Conditions

GISTGastrointestinal Stromal Tumors

Outcome Measures

Primary Outcomes (1)

  • Ct Value (Ct Values From PCR Reaction)

    the number of PCR cycles where the amplification signal starts to be observed

    3 months

Secondary Outcomes (4)

  • PPV

    3 months

  • NPV

    3 months

  • Consistency (the Overall Ratio of True Positive and True Negative)

    3 months

  • Kappa coefficient

    3 months

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospital sample

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Peking University Cancer Hospital

Beijing, China

Location

Harbin Medical University Cancer Hospital

Harbin, China

Location

Shanghai Tenth People's Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2022

First Posted

June 1, 2022

Study Start

November 20, 2020

Primary Completion

February 25, 2021

Study Completion

February 25, 2021

Last Updated

June 6, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(3)