NCT04996095Active, not recruiting
The Registry Study of Genetic Alterations of Esophageal Cancer in Taiwan
Source: ClinicalTrials.gov · Last updated 17 Apr 2025
Brief summary (registry, in English)
Protocol Objectives Establish a platform for sharing integrated database of genetic background, clinical information, and therapeutic outcomes in locally advanced and recurrent/metastatic ESCC. To enroll a total of 400 ESCC patients with different ages and stages according to the eligibility criteria defined in section 5 and section 6.To perform NGS analysis of ESCC tumor tissues, and correlated with the clinical characteristics and treatment outcomes of ESCC patients.To compare the difference of the genetic and molecular profiles among different age groups of ESCC patients.To reveal the evolution changes of genetic and molecular profiles of ESCC by comparing the difference of genetic and molecular alterations between primary and recurrent ESCC and between locally advanced and metastatic ESCC. 。 Study Method, Procedures, and Implementation Status Sample size: 400 patients with ESCC who fit inclusion criteria and exclusion criteria listed in session 6 of the study proposal. 1. To meet the study object of investigating "the difference of the genetic and molecular profiles among different age groups", a minimum of 75 young ESCC patients (with age of ESCC diagnosis at 20-45 years old) and a minimum of 75 elderly ESCC patients (with age of ESCC diagnosis at ≥ 75 years old) will be recruited. 2. To meet the study object of investigating "the evolution changes of genetic and molecular profiles of ESCC", an approximate of 100 recurrent or metastatic ESCC tumors will be included. Centralized Planning Unit and Assisting Unit: Taiwan Cooperative Oncology Group (TCOG), National Health Research Institutes
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 400 (actual)
- First submitted
- 30 Jul 2021
- Start date
- 1 Oct 2021
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- National Health Research Institutes, Taiwan
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT04996095
What you commit to
- Study type: Observational
- Participants enrolled: 400
- From 1 Oct 2021 to the primary completion date, 31 Dec 2029
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 1\. Inability to cooperate by providing a complete medical history. 2. No available tumor tissues for genetic testing. 3. Undesirable compliance. 4. Having a known additional malignancy that is progressing or has required active treatment within the past 3 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., cervical carcinoma in situ) that have undergone potentially curative therapy are not excluded.
Who the study is looking for
- 1\. Cohort 1 (young ESCC): aged 20 \~ 45 years old; Cohort 2 (reference-age ESCC): aged 46 \~ 74 years old); and Cohort 3 (elderly ESCC): aged 75 years or older.
- 2\. Pathological reported as squamous cell carcinoma of the esophagus 3. Staged as clinical or pathological stage II to IVA in loco-regional ESCC group (per AJCC Cancer Staging System 8th edition); stage IVB in the metastatic group; or recurrent status (defined as disease recurrence occurring more than 6 months after curative chemoradiotherapy or surgery) in the recurrent group.
- 4\. Willingness to provide archival or newly obtained tumor tissues for current study proposal.
- 5\. Life expectancy more than 3 months. 6. Patients fully understand the protocol with the willingness to have regular follow-up.
- 6.2. Exclusion Criteria
- Inability to cooperate by providing a complete medical history.
- No available tumor tissues for genetic testing.
- Undesirable compliance.
- Having a known additional malignancy that is progressing or has required active treatment within the past 3 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., cervical carcinoma in situ) that have undergone potentially curative therapy are not excluded.
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shang-Hung Chen Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| Taiwan Cooperative Oncology Group, National Health Research Institutes Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.