Gene Mutation-Related CancerNCT04694391
Genomic Study of Relapse Esophageal Cancer After Radiotherapy
An observational study of Gene Mutation-Related Cancer and Esophageal Cancer, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gene Mutation-Related Cancer, Esophageal Cancer, Radiation Exposure
- What is being tested?
- whole exome sequence
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 14 Sep 2012to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan university shanghai cancer center
Shanghai, 200032
Kuaile Zhao, doctor, 18017312534, kuaile_z@sina.com
Jiaying Deng, doctor, 18317088158, dengjiaying3@sina.com
About this study
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.
Read the 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.
- Being tested
- whole exome sequence
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole exome sequenceGenetic
To seek genomic characteristics of relapsed esophageal cancer with whole exome sequence.
| Study group | Role | What they receive |
|---|---|---|
| Recurrence | The period of recurrence was within 2 years after radiotherapy. Pathologic diagnosis was squamous cell carcinoma same with preradiotherapy. Receives: Genetic: whole exome sequence | |
| No recurrence | The period was more than 3 years after radiotherapy and no recurrence signs were observed. Receives: Genetic: whole exome sequence |
What is being measured
The primary outcome is the main question the study is designed to answer.
genomic characteristics of relapsed esophageal cancer
gene mutations, copy number variants
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start14 Sep 2012
- Primary completion31 Dec 2020
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gene Mutation-Related CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- M.D. Anderson Cancer Center, Nantong University, Jiangsu Cancer Institute & Hospital, Henan Cancer Hospital, Ningbo No.2 Hospital, Taihe Hospital, Taian Cancer Hospital
- Responsible party
- Sponsor
- Investigators
- Kuaile Zhao, doctor, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694391
- Sponsor's protocol ID
- ESO-shanghai 6
- Status last verified
- Jan 2021
- First submitted
- 31 Dec 2020
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genomic Study of Relapse Esophageal Cancer After Radiotherapy
- ClinicalTrials.gov ID
- NCT04694391
- Acronym / sponsor ID
- ESO-shanghai 6
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- M.D. Anderson Cancer Center, Nantong University, Jiangsu Cancer Institute & Hospital, Henan Cancer Hospital, Ningbo No.2 Hospital, Taihe Hospital, Taian Cancer Hospital
- Study start
- 14 Sep 2012 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recurrence | – | Genetic: whole exome sequenceThe period of recurrence was within 2 years after radiotherapy. Pathologic diagnosis was squamous cell carcinoma same with preradiotherapy. |
| No recurrence | – | Genetic: whole exome sequenceThe period was more than 3 years after radiotherapy and no recurrence signs were observed. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| whole exome sequenceTo seek genomic characteristics of relapsed esophageal cancer with whole exome sequence. | Genetic | No recurrence, Recurrence |
Primary outcome
genomic characteristics of relapsed esophageal cancer
Time frame: through study completion, an average of 1 year
gene mutations, copy number variants
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kuaile Zhao, doctor principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gene Mutation-Related Cancer and Esophageal Cancer, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kuaile Zhao, doctor (18017312534, kuaile_z@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
genomic characteristics of relapsed esophageal cancer (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2021.