NCT07489833

Brief Summary

The aim of this study is to integrate insights from metabolomics and TCMBC to identify biomarkers and physiological pathways associated with CRF.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
34mo left

Started Apr 2026

Typical duration for all trials

Status
not yet 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 Progress2%
Apr 2026Feb 2029

First Submitted

Initial submission to the registry

March 18, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2026

Completed
27 days until next milestone

Study Start

First participant enrolled

April 20, 2026

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2029

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

2.7 years

First QC Date

March 18, 2026

Last Update Submit

March 24, 2026

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Self-report Questionnaire

    The study utilizes two instruments. First, the Fatigue Symptom Inventory (FSI) is used to assess fatigue; total scores range from 0 to 127, with higher scores indicating greater fatigue severity. Second, the Body Constitution Questionnaire (BCQ) comprises 16 items, with total scores ranging from 16 to 80.

    Change from baseline to 3 months after surgery.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Newly diagnosed with stage I to III CRC and scheduled for surgical treatment

You may qualify if:

  • Patients aged 18 years or older
  • Diagnosed with stage I to III CRC and scheduled for surgical treatment
  • Cognitively intact and able to communicate in either Mandarin or Taiwanese
  • Willing to participate in the study and provide written informed consent.

You may not qualify if:

  • Patients diagnosed with stage IV colorectal cancer
  • Patients with recurrent colorectal cancer or other concurrent cancers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

The retained samples consist of plasma processed from whole blood. The cellular components (buffy coat and red blood cells) are discarded, and only the acellular plasma fraction is retained for metabolomic analysis related to fatigue mechanisms.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Yun-Jen Chou, PhD

CONTACT

886-3-2118800yjchou@mail.cgu.edu.tw

Study Design

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

Study Record Dates

First Submitted

March 18, 2026

First Posted

March 24, 2026

Study Start

April 20, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

February 28, 2029

Last Updated

March 27, 2026

Record last verified: 2026-03