Method of Differentiating Benignancy and Malignancy, Grading and Staging for GISTNCT03381053
Study to Compare Pathologic Type, NIH and WHO Criteria,and Mechanism of GIST Malignant Transformation
An observational study of Method of Differentiating Benignancy and Malignancy, Grading and Staging for GIST, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Evaluate the reliability of morphology standards for GIST pathologic type, staging and grading by retrospective analyzing clinical data; on this basis, establish a GIST standardized and individualized treatment mode to maximum benefit GIST patients, avoid under- and over-treatment Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- Method of Differentiating Benignancy and Malignancy, Grading and Staging for GIST
- What is being tested?
- Imatinib 400mg
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2017to 1 Jan 2022
- 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 14 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with GIST by pathology
Who may be able to join
- All patients pathologically diagnosed with GIST during the period from 2017 to 2020
Who cannot join
- Only have Biopsy diagnosis
- Only have Liver metastasis or peritoneal dissemination
- Received imatinib treatment before surgery
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
180 Fenglin Road
Shanghai, Shanghai Municipality, 200032
Hou Ying yong, doctor, 13681972385 ext. 86, You.yingyong@zs-hospital.sh.cn
About this study
Official title: Prospective Multicenter Cohort Study to Compare Pathologic Type, NIH and WHO Criteria, and Mechanism of GIST Malignant Transformation
Evaluate the reliability of morphology standards for GIST pathologic type, staging and grading by retrospective analyzing clinical data; on this basis, establish a GIST standardized and individualized treatment mode to maximum benefit GIST patients, avoid under- and over-treatment
Read the detailed description
- Retrospective analysis of GIST cases in the recent five years: the GIST clinical data of Fudan University Zhongshan Hospital from 2007 January to 2012 December were collected. By reviewing the HE slides, GIST was evaluated by 12 indicators, NIH scheme and WHO standard. Accomplish the gene sequencing of KIT, PDGFRA, B-raf, and SDH. Follow up the patients about their treatment and prognosis. Analyze and compare the advantages and disadvantages of the histomorphology indicators, NIH scheme, and WHO standard.
- Organize the first multicenter prospective cohort study of GIST individualized treatment based on the histomorphology. Obtain the evidence of histological assessment for GIST by following up patients for 3 years.
- Establish an evaluation criteria based on the morphology of GIST. Make objective evaluations about GIST tumor size, tumor location and gene mutation status in the prognosis estimate. Make rules to effectively guide individualized treatment of GIST.
- Being tested
- Imatinib 400mg
- Keywords
- GIST, Grading and Staging
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imatinib 400mgDrug
The NIH assessment of patients with surgical excision of GIST with moderate to high risk of recurrence was recommended imatinib 400mg treatment.
| Study group | Role | What they receive |
|---|---|---|
| Treatment observation group | According to the morphological criteria, the NIH scheme, and the WHO standard, GIST patients are divided into two groups, benign group and malignant group. In fully informed of their illness, patients are free to choose the sequence treatments according to their own gene mutation status and economic conditions. Patients who choose postoperative Imatinib treatment are labeled treatment group. Receives: Drug: Imatinib 400mg | |
| Control observation group | According to the morphological criteria, the NIH scheme, and the WHO standard, GIST patients are divided into two groups, benign group and malignant group. In fully informed of their illness, patients are free to choose the sequence treatments according to their own gene mutation status and economic conditions. Patients who choose no Imatinib treatment are labeled observation group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with tumor recurrence
Measured: 3 years
Number of participants with tumor metastasis
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study start1 Jul 2017
- Primary completion1 Jul 2020 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Method of Differentiating Benignancy and Malignancy, Grading and Staging 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ruijin Hospital, Fudan University, Changhai Hospital, Shanghai Changzheng Hospital, Huashan Hospital
- Responsible party
- Sponsor
- Investigators
- Hou Ying Yong, Doctor, Study chair, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03381053
- Sponsor's protocol ID
- SH-GIST2017pathology
- Status last verified
- Dec 2017
- First submitted
- 18 Dec 2017
- Last updated
- 21 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Cohort Study to Compare Pathologic Type, NIH and WHO Criteria, and Mechanism of GIST Malignant Transformation
- ClinicalTrials.gov ID
- NCT03381053
- Acronym / sponsor ID
- SH-GIST2017pathology
- Keywords
- GIST, Grading and Staging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Ruijin Hospital, Fudan University, Changhai Hospital, Shanghai Changzheng Hospital, Huashan Hospital
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 21 Dec 2017 (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.
Evaluate the reliability of morphology standards for GIST pathologic type, staging and grading by retrospective analyzing clinical data; on this basis, establish a GIST standardized and individualized treatment mode to maximum benefit GIST patients, avoid under- and over-treatment
Detailed description
- Retrospective analysis of GIST cases in the recent five years: the GIST clinical data of Fudan University Zhongshan Hospital from 2007 January to 2012 December were collected. By reviewing the HE slides, GIST was evaluated by 12 indicators, NIH scheme and WHO standard. Accomplish the gene sequencing of KIT, PDGFRA, B-raf, and SDH. Follow up the patients about their treatment and prognosis. Analyze and compare the advantages and disadvantages of the histomorphology indicators, NIH scheme, and WHO standard.
- Organize the first multicenter prospective cohort study of GIST individualized treatment based on the histomorphology. Obtain the evidence of histological assessment for GIST by following up patients for 3 years.
- Establish an evaluation criteria based on the morphology of GIST. Make objective evaluations about GIST tumor size, tumor location and gene mutation status in the prognosis estimate. Make rules to effectively guide individualized treatment of GIST.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment observation group | – | Drug: Imatinib 400mgAccording to the morphological criteria, the NIH scheme, and the WHO standard, GIST patients are divided into two groups, benign group and malignant group. In fully informed of their illness, patients are free to choose the sequence treatments according to their own gene mutation status and economic conditions. Patients who choose postoperative Imatinib treatment are labeled treatment group. |
| Control observation group | – | –According to the morphological criteria, the NIH scheme, and the WHO standard, GIST patients are divided into two groups, benign group and malignant group. In fully informed of their illness, patients are free to choose the sequence treatments according to their own gene mutation status and economic conditions. Patients who choose no Imatinib treatment are labeled observation group. |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with GIST by pathology
Key inclusion criteria (1 listed)
- All patients pathologically diagnosed with GIST during the period from 2017 to 2020
Key exclusion criteria (3 listed)
- Only have Biopsy diagnosis
- Only have Liver metastasis or peritoneal dissemination
- Received imatinib treatment before surgery
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 |
|---|---|---|
| Imatinib 400mgThe NIH assessment of patients with surgical excision of GIST with moderate to high risk of recurrence was recommended imatinib 400mg treatment. | Drug | Treatment observation group |
Primary outcome
Number of participants with tumor recurrence
Time frame: 3 years
Number of participants with tumor metastasis
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2017.
- Individual participant dataSharing planned: No
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.
Hou Ying Yong, Doctor study chair
Shanghai Zhongshan 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 Method of Differentiating Benignancy and Malignancy, Grading and Staging for GIST, run by Shanghai Zhongshan 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 1 inclusion and 3 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 21 Dec 2017. 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?
Contact Hou Ying Yong, Doctor (13681972385 ext. 86, Hou.yingyong@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with tumor recurrence (time frame: 3 years). The study lists 2 primary outcomes in all. 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 21 Dec 2017.