MRD Test in Common Risk Stage II Colorectal Cancer | NCT05795010

Studies
MRD Test in Common Risk Stage II Colorectal Cancer

NCT05795010

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Status

Unknown status

Last Update Posted

Apr 3, 2023Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Stage II Colorectal Cancer

Interventions

MRD test

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 30, 2023Estimated

Primary Completion Date

Apr 10, 2023Estimated

Completion Date

Sep 30, 2023Estimated

First Submitted Date

Mar 7, 2023

First Submission Date that Met QC Criteria

Mar 29, 2023

First Posted Date

Apr 3, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2023

Last Update Posted Date

Apr 3, 2023Actual

Name	Class
Second Affiliated Hospital of Xi'an Jiaotong University	OTHER

Description Module

Brief Summary

Patients with colorectal cancer who were confirmed as stage II general risk type in the postoperative pathological report began to be enrolled. Observe the sensitivity of the detection of micro-MRD before operation and the postoperative positive rate of this type of patients.

Detailed Description

This observation part is about the patients with general risk stage II colorectal cancer who have received R0 resection after screening by nanofiltration criteria. Twenty milliliters of venous blood samples were reserved before surgery, and tumor tissue samples were reserved within 30 minutes in vitro during surgery. After the pathological diagnosis of the patients after surgery, they began to be enrolled. To observe the sensitivity of MRD detection in preoperative diagnosis of patients with general risk stage II colorectal cancer, and to study its positive rate one month and three months after operation.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

60Estimated

Name	Type	Description	Arm Group Labels	Other Names
MRD test	Other	ctDNA detection based on tumor whole exon sequencing		ctDNA test

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Positive rate of preoperative MRD test	To observe the positive rate of preoperative MRD detection for stage II colorectal cancer	six months

Secondary Outcomes

Measure	Description	Time Frame
Positive rate of MRD test 1 month and 3 months after operation	Observe the positive rate of MRD detection at 1 month and 3 months after operation for stage II colorectal cancer	nine months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-75;
Pathologically confirmed rectal adenocarcinoma;
Pathological differentiation is highly or moderately differentiated;
The pathological stage was pT3N0, that is, invasion of the proper muscular layer of the intestinal wall without lymph node metastasis;
No new adjuvant treatment before operation
There was no vascular infiltration and nerve infiltration in postoperative pathology;
No preoperative intestinal obstruction or tumor site perforation;
No postoperative pathological margin was positive or unknown;
The distance between the pathological cutting edge and the tumor was more than 1 cm;
Invasion of mesentery of intestinal wall ≤ 2mm;
More than 12 lymph nodes were submitted for examination;
Nonlocal recurrence and distant metastasis;
No multiple primary carcinoma of colon and rectum;
Physical condition score PS ≤ 2 points;
Patients and their families can understand and are willing to participate in this study and provide written informed consent.

Exclusion Criteria:

Multiple intestinal carcinomatosis
Previous history of malignant tumor,
There are concurrent malignant tumors in the whole body except for colorectal cancer
Colorectal cancer with preoperative anti-tumor treatment
Pregnant or lactating women
There are serious complications during or after operation, affecting the prognosis
Hepatitis B or Hepatitis C antibody positive
HIV antibody positive
Other diseases considered by the research doctor to affect the prognosis and survival
Other conditions that the research doctor believes are not consistent with this study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Preoperative venous blood and intraoperative tumor tissue samples were reserved for patients with colorectal cancer who were estimated as stage II general risk type by pelvic magnetic resonance imaging. Patients with colorectal cancer who were confirmed as stage II general risk type in the postoperative pathological report began to be enrolled

Sampling Method

Probability Sample

Name	Role	Phone	Extension	Email
Yongchun Song, MD	Contact	0086-18991232549		758327495@qq.com
Gang Xu, MD	Contact	0086-15829030108

Name	Affiliation	Role
Yongchun Song, MD	First Affiliated Hospital of Xian Jiaotong University	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
First Affiliated Hospital of Xian Jiaotong University		Xi'an	Shaanxi	710061	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31070691	Background	Reinert T, Henriksen TV, Christensen E, Sharma S, Salari R, Sethi H, Knudsen M, Nordentoft I, Wu HT, Tin AS, Heilskov Rasmussen M, Vang S, Shchegrova S, Frydendahl Boll Johansen A, Srinivasan R, Assaf Z, Balcioglu M, Olson A, Dashner S, Hafez D, Navarro S, Goel S, Rabinowitz M, Billings P, Sigurjonsson S, Dyrskjot L, Swenerton R, Aleshin A, Laurberg S, Husted Madsen A, Kannerup AS, Stribolt K, Palmelund Krag S, Iversen LH, Gotschalck Sunesen K, Lin CJ, Zimmermann BG, Lindbjerg Andersen C. Analysis of Plasma Cell-Free DNA by Ultradeep Sequencing in Patients With Stages I to III Colorectal Cancer. JAMA Oncol. 2019 Aug 1;5(8):1124-1131. doi: 10.1001/jamaoncol.2019.0528.
35750857

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site