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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03615170
Other study ID # ZJCH-CRC-201708
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 19, 2017
Est. completion date December 31, 2022

Study information

Verified date May 2019
Source Zhejiang Cancer Hospital
Contact Luying Liu
Phone 0571-88128142
Email luyingliu@163.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Application of circulating tumor DNA detection in diagnosis and treatment of locally advanced rectal cancer. First, to explore the feasibility of ctDNA as a detection index for rectal cancer. Second, evaluate the accuracy of ctDNA detection in rectal cancer. Third, to explore whether ctDNA can be used in the evaluation of preoperative concurrent chemoradiotherapy, so as to provide guidance for subsequent treatment. Fourth, to explore the guidance value for the decision of postoperative adjuvant therapy and the frequency of reexamination. Fifth, search for possible recurrence related mutations.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 31, 2022
Est. primary completion date March 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Histologically or cytologically confirmed primary rectal cancer;

- First treatment;

- 18 years of age or older, male or female;

- According to the indications of operation, surgical treatment can be carried out;

- According to the indications of radiotherapy, radiotherapy can be carried out;

- The physical status score of ECOG was 0~1;

- Organ function is appropriate;

- Expected survival time more than 3 months;

- During the treatment period and 6 months after treatment, contraception was not in lactation;

- The patient volunteered and signed the informed consent.

Exclusion Criteria:

- Poor compliance and failure to receive medication or follow up according to plan;

- There are other serious violations of the programme;

- At present, it has been included in other clinical trials, or at the same time, it has been included in other medical research which is judged to be incompatible with this research;

- It has a history of other cancers. Unless the cancer is completely relieved, the disease is not treated for more than 3 years.

Study Design


Locations

Country Name City State
China Zhejiang Cancer Hospital Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Disease free survival Disease free survival 3 year
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