Prediction Model of Response for CCRT in Esophageal Cancer

NCT03081988 | Unknown DMC

• 1 other identifier: 2015R1D1A1A01059219
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

• naive esophageal cancer patients who have a plan to receive concomitant chemo-radiotherapy
• acquirement of tissue, blood, clinical information
• isolation of RNA, DNA, serum database of clinical \& demographic information \*\*\*Analysis of mRNA sequencing / miRNA sequencing\*\*\*\* first analysis of RNA sequencing: bioinformatician second analysis of RNA sequencing: principle investigator
• Experimental set for qPCR (esophageal tissue) study group
• TMA for screened exon gene
• validation set for qPCR (esophageal tissue)
• follow-up of circulating miRNA in blood (baseline blood \& post-CCRT blood 3M, 6M, 12M)
• Prediction model for CCRT response in esophageal Cancer based on clinical and molecular factors
• Validate the prediction model.

Conditions

Esophageal Cancer

Keywords

Esophageal Cancer; chemoradiotherapy response; molecular factors

Outcome Measures

Primary Outcomes (1)

• Prediction model for CCRT response based on clinical and genetic molecular factors

  prediction model for CCRT response based on clinical and genetic molecular factors in esophageal cancer

  up to 36 months

Secondary Outcomes (4)

• banking of remained human material for post genetic & molecular study

  up to 10 years

• circulating preditction marker for CCRT response and prognosis

  up to 5 years

• tissue prediction marker for CCRT response and prognosis

  up to 5 years

• in-vitro prediction of CCRT using primary esophageal cancer organoid

  up to 6 month

Other Outcomes (1)

• Clinical prediction factors for CCRT response (retrospective study)

  up to 5 years

Study Arms (2)

Responder

Complete Remission after chemoradiotherapy in locally advanced or advanced esophageal cancer evaluation of disease status: endoscopy, CT, and/or PET-CT

Other: chemoradiotherapy

non-responder

Progressive disease or stationary state after chemoradiotherapy in locally advanced or advanced esophageal cancer evaluation of disease status: endoscopy, CT, and/or PET-CT

Other: chemoradiotherapy

Interventions

chemoradiotherapy OTHER

concomitant chemoradiotherpay is routine treatment in locally advanced and advanced esophageal cancer and it is not for research.

Responder; non-responder

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

locally advanced or advanced esophageal cancer who want concomitant chemoradiotherapy

You may qualify if:

• locally advanced or advanced esophageal cancer who want concomitant chemoradiotherapy
• persons who assigned the written informed consents.

You may not qualify if:

• persons who did't assign the informed consents
• other organ cancer
• heavy alcoholics

Sponsors & Collaborators

• Kyungpook National University Hospital: lead

Study Sites (1)

Kyungpook National University Medical Canter

Daegu, 41404, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

esophageal cancer tissue and paired normal tissue serum, plasma, buffy coat (DNA), whole blood (RNA)

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Chemoradiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Study Officials

• Su Youn Nam, MD, PhD

  Kyungpook National University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Su Youn Y Nam, MD, PhD

CONTACT

82-53-200-2610; nam20131114@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 18, 2017
• First Posted: March 17, 2017
• Study Start: October 19, 2015
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 4, 2023

Record last verified: 2023-10

Locations

KR (1)