NCT04694391

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 14, 2012

Completed
8.3 years until next milestone

First Submitted

Initial submission to the registry

December 31, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

8.3 years

First QC Date

December 31, 2020

Last Update Submit

January 24, 2021

Conditions

Gene Mutation-Related CancerEsophageal CancerRadiation Exposure

Outcome Measures

Primary Outcomes (1)

  • genomic characteristics of relapsed esophageal cancer

    gene mutations, copy number variants

    through study completion, an average of 1 year

Study Arms (2)

Recurrence

The period of recurrence was within 2 years after radiotherapy. Pathologic diagnosis was squamous cell carcinoma same with preradiotherapy.

Genetic: whole exome sequence

No recurrence

The period was more than 3 years after radiotherapy and no recurrence signs were observed.

Genetic: whole exome sequence

Interventions

whole exome sequenceGENETIC

To seek genomic characteristics of relapsed esophageal cancer with whole exome sequence.

No recurrenceRecurrence

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan university shanghai cancer center

Shanghai, 200032, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

DNA was extracted from all samples to conduct exome sequence. The investigators attempt to seek genomic characteristics of relapsed esophageal cancer after radiotherapy.

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

  • Kuaile Zhao, doctor

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kuaile Zhao, doctor

CONTACT

18017312534kuaile_z@sina.com

Jiaying Deng, doctor

CONTACT

18317088158dengjiaying3@sina.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 31, 2020

First Posted

January 5, 2021

Study Start

September 14, 2012

Primary Completion

December 31, 2020

Study Completion

December 31, 2022

Last Updated

January 26, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)