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
Eligibility
Sex
ALL
Min age
20 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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
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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
Analysis of Predictive Markers — 5 year 440 cancer-related genes, 31 fusion genes, 500X coverage and the panel size larger than 1MB
Trial sites (2)
Facility
City
Region
Status
Shang-Hung Chen
Tainan
Taiwan
Taiwan Cooperative Oncology Group, National Health Research Institutes
Taipei
Taiwan
More National Health Research Institutes, Taiwan trials in Taiwan
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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