Improve the Screening Criteria of Chinese Hereditary Upper Gastrointestinal TumorsNCT03130621
Screening of Hereditary Upper Gastrointestinal Cancer in China
An observational study of Improve the Screening Criteria of Chinese Hereditary Upper Gastrointestinal Tumors, run by Peking University at 1 site in China.
Trial summary
Through exploring the specific genetic mutations in the upper gastrointestinal tract tumors with a family history and specific clinical pathological types，we establish a complete family and follow-up system，in order to improve the screening criteria of Chinese hereditary upper gastrointestinal tumors and carry on… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Improve the Screening Criteria of Chinese Hereditary Upper Gastrointestinal Tumors
- What is being tested?
- Gene detection
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Jan 2017to Mar 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Upper Gastrointestinal Cancer
Who may be able to join
- Patients with gastric cancer, esophageal adenocarcinoma, or duodenal adenocarcinoma meet one of the following criteria:
- age≤30;
- age≤35，gastric cancer with special pathological types;
- age≤50，≥one first-degree relative of a malignant tumor;
- ≥ two first-degree／second-degree relatives of a malignant tumor，and ≥one first-degree relative;
- have ≥two types of malignancies，and age ≤50 at the first time of diagnosis;
Show all 11Show fewer
- MSI or dMMR of tissue specimen;
- Patients with esophageal squamous cell carcinomas meet one of the following criteria:
- ≥ two first-degree／second-degree relatives of a malignant tumor，and ≥one first-degree relative;
- have ≥two types of malignancies，and age ≤50 at the first time of diagnosis;
- MSI or dMMR of tissue specimen;
Who cannot join
- Patients do not meet one of the inclusion criteria;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Shen Lin, Professor, 010-88196561, Linshenpku@163.com
Shen Lin, professor
About this study
Through exploring the specific genetic mutations in the upper gastrointestinal tract tumors with a family history and specific clinical pathological types，we establish a complete family and follow-up system，in order to improve the screening criteria of Chinese hereditary upper gastrointestinal tumors and carry on primary prevention of disease.
- Being tested
- Gene detection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gene detectionDiagnostic test
Next-generation sequencing
| Study group | Role | What they receive |
|---|---|---|
| Adenocarcinoma of upper digestive tract | Early-onset carcinomas ; Family History of Malignancy; Special pathological type; MSI or dMMR; Multiple primary malignant tumors; Receives: Diagnostic Test: Gene detection | |
| Esophageal squamous cell carcinoma | Family History of Malignancy; Multiple primary malignant tumors; MSI or dMMR; Receives: Diagnostic Test: Gene detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pedigree analysis
We plan to analyse the families of patients who met the inclusion criterias through gene detection.
Measured: In the first phase of the project, we plan to detect 40-50 families in one year. And in the second phase，we will increase the number of predigree to 200. We hope to finish the phase before 2022.3
Secondary outcomes (1)
somatic mutation landscape of hereditary upper gastrointestinal cancer
By comparing the landscape of somatic mutation of patients with different pathogenic germiline mutation , we want to explore the pathogenesis and molecule mechanism of hereditary upper digestive tract tumors.
Measured: We plan to accomplish sample collection, sequencing and data analysis before 2022.3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study startJan 2017
- Primary completionMar 2022 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Improve the Screening Criteria of Chinese Hereditary Upper Gastrointestinal TumorsStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- 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
- Family based
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen Lin, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130621
- Sponsor's protocol ID
- CGOG1012
- Status last verified
- Jun 2019
- First submitted
- 22 Apr 2017
- Last updated
- 4 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening of Hereditary Upper Gastrointestinal Cancer in China
- ClinicalTrials.gov ID
- NCT03130621
- Acronym / sponsor ID
- CGOG1012
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 26 Apr 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.
Through exploring the specific genetic mutations in the upper gastrointestinal tract tumors with a family history and specific clinical pathological types，we establish a complete family and follow-up system，in order to improve the screening criteria of Chinese hereditary upper gastrointestinal tumors and carry on primary prevention of disease.
Study design
- Observational model
- Family based
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adenocarcinoma of upper digestive tract | – | Diagnostic Test: Gene detectionEarly-onset carcinomas ; Family History of Malignancy; Special pathological type; MSI or dMMR; Multiple primary malignant tumors; |
| Esophageal squamous cell carcinoma | – | Diagnostic Test: Gene detectionFamily History of Malignancy; Multiple primary malignant tumors; MSI or dMMR; |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Upper Gastrointestinal Cancer
Key inclusion criteria (11 listed)
- Patients with gastric cancer, esophageal adenocarcinoma, or duodenal adenocarcinoma meet one of the following criteria:
- age≤30;
- age≤35，gastric cancer with special pathological types;
- age≤50，≥one first-degree relative of a malignant tumor;
- ≥ two first-degree／second-degree relatives of a malignant tumor，and ≥one first-degree relative;
Key exclusion criteria (1 listed)
- Patients do not meet one of the inclusion criteria;
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 |
|---|---|---|
| Gene detectionNext-generation sequencing | Diagnostic test | Adenocarcinoma of upper digestive tract, Esophageal squamous cell carcinoma |
Primary outcome
Pedigree analysis
Time frame: In the first phase of the project, we plan to detect 40-50 families in one year. And in the second phase，we will increase the number of predigree to 200. We hope to finish the phase before 2022.3
We plan to analyse the families of patients who met the inclusion criterias through gene detection.
1 secondary outcome
somatic mutation landscape of hereditary upper gastrointestinal cancer
Time frame: We plan to accomplish sample collection, sequencing and data analysis before 2022.3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
- 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.
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 Improve the Screening Criteria of Chinese Hereditary Upper Gastrointestinal Tumors, run by Peking University 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 11 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 4 Jun 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pedigree analysis (time frame: In the first phase of the project, we plan to detect 40-50 families in one year. And in the second phase，we will increase the number of predigree to 200. We hope to finish the phase before 2022.3). 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 4 Jun 2019.