Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Guangzhou Burning Rock Dx Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to detect the prognostic value of longitudinal monitoring circulating tumor DNA (ctDNA) for no evidence of disease (NED) status in metastatic colorectal cancer (mCRC) patients and its utility in guiding therapeutic intervention. The main questions it aims to answer are:
Patients who receive any kinds of therapies with the aim of NED and are confirmed by clinical and radiologic examination will go through longitudinal ctDNA monitoring. According to the results of ctDNA monitoring, the patients will be divided into ctDNA positive group and ctDNA negative group. Patients in ctDNA positive group will receive individual therapeutic plan decided by the investigator. Patients in ctDNA negative group will receive regular examinations. When radiologic recurrences are confirmed, the patients will be re-evaluated for a second opportunity of radical resection.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ctDNA positive | Experimental |
| |
| ctDNA negative | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ctDNA and adjuvant therapy | Other | Patients of ctDNA positive group receive individual adjuvant chemotherapy. The ctDNA status are evaluated every 2 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relapse-free survival (RFS) time | To detect the RFS time in metastatic colorectal cancer (mCRC) patients with no evidence of disease (NED) status who received circulating tumor DNA (ctDNA) guided therapies. | From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) time | To detect the OS time in mCRC patients with NED status who received ctDNA guided therapies. | From the date of surgery until the date of death from any cause, assessed up to 2 years. |
| The positive rate of ctDNA in mCRC patients with NED status. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junjie Peng | Contact | +86-021-64175590 | pengjj67@hotmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| D000074141 | Circulating Tumor DNA |
| ID | Term |
|---|---|
| D000073888 | Cell-Free Nucleic Acids |
| D009696 | Nucleic Acids |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004273 | DNA, Neoplasm |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ctDNA | Other | Patients of ctDNA negative group are monitored by ctDNA every 3 months. |
|
When the NED status is confirmed by radiology post-operation, it will also be assessed the ctDNA positive rate. |
| Post-operation 1 month |
| The concordance index of ctDNA defined NED and radiology defined NED status. | In this study, we aim to evaluate the NED status by ctDNA and traditional radiologic methods. The concordance index will be used to detect the identity of two methods. | When the clinic trail is finished, up to 2 years. |
| The rate of achieving NED status when relapses happen. | When the diseases relapse during the follow-up. The multi-disciplinary treatment (MDT) team will discuss the opportunities to achieve a second NED status. | When the relapses happen, up to 2 years. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D004247 | DNA |