NCT05871762

Brief Summary

The purpose of this study is to compare the efficacy, prognosis, health economics of different treatment modalities of mid-low rectal cancer in different centers in China, and to conduct cost utility analysis (CUA) on the treatment process of rectal cancer to explore the best treatment modality that meets the actual need of medical units in each region and at each level. The investigators hope to provide evidence-based medical suggestions for medical quality control of rectal cancer and revision of clinical guidelines, and provides a source of decision making for medical management and medical insurance.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,705

participants targeted

Target at P75+ for all trials

Timeline
11mo left

Started Jun 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Jun 2023May 2027

First Submitted

Initial submission to the registry

May 10, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 23, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

June 4, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2027

Last Updated

August 28, 2023

Status Verified

August 1, 2023

Enrollment Period

4 years

First QC Date

May 10, 2023

Last Update Submit

August 24, 2023

Conditions

Rectal Neoplasms

Outcome Measures

Primary Outcomes (1)

  • 3-year OS

    3-year overall survival

    3 years

Secondary Outcomes (10)

  • 3-year DFS

    3 years

  • 3-year LR

    3 years

  • 3-year distant metastasis rate

    3 years

  • neoadjuvant therapy rate

    at the time point of surgery of the primary lesion

  • adjuvant therapy rate

    at the time point of 3-year follow up

  • +5 more secondary outcomes

Interventions

Registry study, no specific interventionOTHER

Registry study, no specific intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

mid-low rectal cancer patients

You may qualify if:

  • pathologically confirmed rectal adenocarcinoma
  • located within 12cm below the anal verge

You may not qualify if:

  • diagnosed with distant metastasis
  • multiple primary colorectal cancers
  • history of previous malignant tumors
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Yi Xiao, Professor

CONTACT

+86 13366036387Xiaoy@pumch.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2023

First Posted

May 23, 2023

Study Start

June 4, 2023

Primary Completion (Estimated)

May 17, 2027

Study Completion (Estimated)

May 17, 2027

Last Updated

August 28, 2023

Record last verified: 2023-08

Locations

CN(1)