The Registry Study of Genetic Alterations of Esophageal Cancer in Taiwan

NCT04996095 | Active Not Recruiting DMC

• 1 other identifier: TCOG T4221
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 2

Brief Summary

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. 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. 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

Conditions

Esophageal Cancer

Keywords

esophageal cancer; precision medicine

Outcome Measures

Primary Outcomes (1)

• Analysis of Predictive Markers

  440 cancer-related genes, 31 fusion genes, 500X coverage and the panel size larger than 1MB

  5 year

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

1 ESCC: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.

You may qualify if:

• \. 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.
• \. 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.
• \. Willingness to provide archival or newly obtained tumor tissues for current study proposal.
• \. Life expectancy more than 3 months. 6. Patients fully understand the protocol with the willingness to have regular follow-up.

You may not qualify if:

• 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.
• \. 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.

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead
• National Cheng-Kung University Hospital: collaborator
• National Taiwan University Hospital: collaborator
• Kaohsiung Medical University Chung-Ho Memorial Hospital: collaborator
• Taipei Veterans General Hospital, Taiwan: collaborator
• Chang Gung Memorial Hospital: collaborator

Study Sites (2)

Shang-Hung Chen

Tainan, Taiwan

Location

Taiwan Cooperative Oncology Group, National Health Research Institutes

Taipei, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

1. Tumor Sample(s): One H\&E staining slide, and 10-15 tissue slides (4-5 um thickness) for cancer panel. 2. Details of Tests/Collaborative Test Unit: Testing will take place in a certified precision medicine laboratory. 3. Non-tumor Sample (Blood): Eighteen (18) ml of blood will be collected from the participant: 10 ml in EDTA tube (purple top) and 8 ml in Cell-Free DNA blood collection tube.

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Chih-Hung Hsu, MD,PHD

  National Taiwan University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2021
• First Posted: August 9, 2021
• Study Start: October 1, 2021
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 17, 2025

Record last verified: 2025-04

Locations

TW (2)