RASi for Preventing Postoperative Recurrence of Stage II/... | NCT07012538

Studies
RASi for Preventing Postoperative Recurrence of Stage II/III Colon Cancer

NCT07012538

Sponsor

Fudan University

Status

Completed

Last Update Posted

Jun 10, 2025Actual

Enrollment

2,640Actual

Phase

Not provided

Conditions

Colon Cancer (Stage II &Amp;Amp; III)

Interventions

Renin-angiotensin system inhibitors (RASi)
No renin-angiotensin system inhibitors (No RASi)

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

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 4, 2012Actual

Primary Completion Date

Dec 30, 2021Actual

Completion Date

Apr 30, 2025Actual

First Submitted Date

May 30, 2025

First Submission Date that Met QC Criteria

May 31, 2025

First Posted Date

Jun 10, 2025Actual

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

May 31, 2025

Last Update Posted Date

Jun 10, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this retrospective cohort study is to learn about the long-term effects of renin-angiotensin system inhibitors (RASi) in preventing patients with hypertension and stage II/III colon cancer from recurrence and metastases after radical resection. The main question it aims to answer is:

Does RASi improve the 3-year disease-free survival of patients with hypertension and stage II/III colon cancer after surgery? Participants with hypertension and already having radical resection of stage II/III colon cancer will be followed up for 3 years.

Detailed Description

Previous studies have shown that renin-angiotensin system inhibitors (RASi) may reduce postoperative recurrence and metastases of colorectal cancer. However, the relevant clinical evidences were low level and controversial. This study retrospectively collect patients with hypertension and stage II/III colon cancer after radical resection, and compare the patients with vs. without RASi in terms of long-term oncological outcomes, to study the inhibitory effect of RASi on recurrence and metastasis.

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

No data available

No data is available for this block.

Enrollment

2,640Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Renin-angiotensin system inhibitors (RASi)		Using RASi after radical resection of stage II/III colon cancer	Drug: Renin-angiotensin system inhibitors (RASi)
No renin-angiotensin system inhibitors (No RASi)		Not using RASi after radical resection of stage II/III colon cancer	Drug: No renin-angiotensin system inhibitors (No RASi)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Renin-angiotensin system inhibitors (RASi)	Drug	Using RASi after radical resection of stage II/III colon cancer for at least 3 years or till recurrence or death or inappropriate use of RASi.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
3-year disease-free survival	The events of 3-year disease-free survival are defined as any recurrence of metastases or death within 3 years after surgery.	3 years after surgery

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
3-year overall survival	The events of 3-year overall survival are defined as any death within 3 years after surgery.	3 years after surgery

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Inferior tumor edge > 15 cm from anal verge;
Received radical resection of primary tumor;
Pathological proved stage II or stage III adenocarcinoma;
No evidence of distant metastases at time of surgery (including pelvis, peritoneum, liver, lung, brain, bone, distant lymph node, etc), according to ultrasound, CT, MRI, PET-CT, intraoperative exploration, etc;
Combined with hypertension at time of surgery;
No other malignancies in medical history except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri;
Informed consent.

Exclusion Criteria:

Emergency surgery for acute intestinal obstruction, bleeding, perforation, etc;
Multiple primary colorectal cancer;
Hereditary colorectal cancer (familial adenomatosis polyposis, Lynch Syndrome, etc.);
Co-existent inflammatory bowel disease;
Pregnancy or lactation;
Received any of preoperative anti-cancer treatment.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with hypertension and stage II/III colon cancer, received radical resection of the primary tumor.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhongshan Hospital Fudan University		Shanghai	Shanghai Municipality	200032	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Whether to share the IPD will be decided after the research paper is published.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003110	Colonic Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

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