Application of Circulating Tumor DNA Test in the Diagnosis and Treatment of Patients With Advanced Rectal Cancer

Rectal Neoplasms Clinical Trial

Official title:

Application of Circulating Tumor DNA Test in the Diagnosis and Treatment of Patients With Advanced Rectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03615170
• Other study ID #: ZJCH-CRC-201708
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Circulating Tumor DNA
• Neoadjuvant Therapy
• Rectal Neoplasms

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