Genomic Study of Relapse Esophageal Cancer After Radiotherapy

January 24, 2021 updated by: Fudan University
Radiotherapy plays an important role in multidisciplinary treatment of esophageal cancer. However, about half patients received radiotherapy occurred relapse. Once relapse occurred, there is no better treatment strategy. Genomic study of relapsed esophageal cancer is seldom. So the investigators attempt to collect relapsed tissue to conduct with whole exome sequencing in order to investigate the genome landscape of recurrence esophageal cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Tumor tissue of patients received radiotherapy with diagnosis of recurrence between Jan 1, 2010 and Dec 1, 2020 were collected retrospectively. Recurrence tumor tissue is collected between Dec 31, 2020 and Dec 31, 2022 prospectively. Blood and preradiotherapy tumor tissue were also collected to be as contrast. A total of 100 paired blood, preradiotherapy tumor tissue and relapse tumor tissue were collected. What is more, a total of 100 paired blood and preradiotherapy tumor tissue with diagnosis of no recurrence were collected. All samples were conducted with whole exome sequencing.

Here the investigators define recurrence period as within 2 years and no recurrence period as more than 3 years after radiotherapy.

Criteria of relapse: (1) pathologic diagnosis is squamous carcinoma before radiotherapy;(2) received radiotherapy; (3)pathologic diagnosis is also squamous carcinoma after radiotherapy; (4) clinical symptoms including feeding obstruction etc; (5) imaging evidence showed disease progression.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Recurrence group: 100 paired relapsed tumor tissue,blood and preradiotherapy tumor tissue within 2 years after radiotherapy were collected.

No recurrence group:100 paired blood and preradiotherapy tumor tissue with more than 3 years after radiotherapy were collected

Description

Inclusion Criteria:

  1. pathologic diagnosis is squamous cell carcinoma before radiotherapy;
  2. pathologic diagnosis is squamous cell carcinoma after radiotherapy;
  3. received radiotherapy
  4. clinical symptoms including dysphagia, feeding obstruction, etc
  5. image evidence showed disease progression
  6. the period of recurrence was within 2 years after radiotherapy

Exclusion Criteria:

  1. pathologic diagnosis is not squamous cell carcinoma before radiotherapy;
  2. pathologic diagnosis is not squamous cell carcinoma after radiotherapy
  3. not received radiotherapy
  4. the period of recurrence was more than 2 years after radiotherapy
  5. the period of no recurrence was within 3 years after radiotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Recurrence
The period of recurrence was within 2 years after radiotherapy. Pathologic diagnosis was squamous cell carcinoma same with preradiotherapy.
Genetic: whole exome sequence
To seek genomic characteristics of relapsed esophageal cancer with whole exome sequence.
No recurrence
The period was more than 3 years after radiotherapy and no recurrence signs were observed.
Genetic: whole exome sequence
To seek genomic characteristics of relapsed esophageal cancer with whole exome sequence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
genomic characteristics of relapsed esophageal cancer
Time Frame: through study completion, an average of 1 year
gene mutations, copy number variants
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Collaborators

M.D. Anderson Cancer Center
Henan Cancer Hospital
Jiangsu Cancer Institute & Hospital
Nantong University
Ningbo No.2 Hospital
Taihe Hospital
Taian Cancer Hospital

Investigators

  • Principal Investigator: Kuaile Zhao, doctor, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2012

Primary Completion (Actual)

December 31, 2020

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

December 31, 2020

First Submitted That Met QC Criteria

January 2, 2021

First Posted (Actual)

January 5, 2021

Study Record Updates

Last Update Posted (Actual)

January 26, 2021

Last Update Submitted That Met QC Criteria

January 24, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESO-shanghai 6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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