NCT06614660

Brief Summary

In this study, the investigators constructed an imaging-metabolism prediction model for colorectal cancer by analysing the imaging and metabolomics features of colorectal cancer, in order to further adjust and guide the treatment plan.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
17mo left

Started Sep 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not 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 Progress56%
Sep 2024Sep 2027

Study Start

First participant enrolled

September 1, 2024

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2024

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

September 27, 2024

Status Verified

September 1, 2024

Enrollment Period

3 years

First QC Date

September 24, 2024

Last Update Submit

September 26, 2024

Conditions

Keywords

colorectai cacnerimaging genomicsmetabolomics genomicsprognosis

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Overall survival was defined as time from date of diagnosis until the date of death from any cause or or loss to follow-up.

    From date of diagnosis until the date of death from any cause or or loss to follow-up, whichever came first, assessed up to 60 months.

Study Arms (1)

the colorectal cancer group

Metabolism genomics and imaging genomics were collected via blood and CT images for colorectal cancer patients.

Other: Metabolism genomics and imaging genomics

Interventions

Pre-operative imaging images of the patient were collected prior to surgery, and 2 ml of the patient\'s blood specimen was collected to collect metabolism genomics and imaging genomics.

the colorectal cancer group

Eligibility Criteria

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

Adult patients diagnosed with colorectal cancer and undergoing radical surgery for colorectal cancer at this clinic center were invited.

You may qualify if:

  • met the diagnostic criteria for gastrointestinal tumours;
  • age \>18 years;
  • planned to undergo surgery for gastrointestinal tumours according to the guidelines;
  • signed an informed consent form; and e) agreed to undergo a biopsy in order to collect tissue from the tumour lesion.

You may not qualify if:

  • contraindications to imaging;
  • withdrawal from the study cohort midway;
  • metastatic foci in the liver, lung or other distant organs confirmed by CT, MRI or ultrasound imaging;
  • gastrointestinal tumours combined with haemorrhage, obstruction or perforation;
  • women who were pregnant, breastfeeding or planning to become pregnant during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

Related Publications (3)

  • Zhang G, Zhang Z, Pei Y, Hu W, Xue Y, Ning R, Guo X, Sun Y, Zhang Q. Biological and clinical significance of radiomics features obtained from magnetic resonance imaging preceding pre-carbon ion radiotherapy in prostate cancer based on radiometabolomics. Front Endocrinol (Lausanne). 2023 Oct 20;14:1272806. doi: 10.3389/fendo.2023.1272806. eCollection 2023.

    PMID: 38027108BACKGROUND
  • Cicalini I, Chiarelli AM, Chiacchiaretta P, Perpetuini D, Rosa C, Mastrodicasa D, d'Annibale M, Trebeschi S, Serafini FL, Cocco G, Narciso M, Corvino A, Cinalli S, Genovesi D, Lanuti P, Valentinuzzi S, Pieragostino D, Brocco D, Beets-Tan RGH, Tinari N, Sensi SL, Stuppia L, Del Boccio P, Caulo M, Delli Pizzi A. Multi-omics staging of locally advanced rectal cancer predicts treatment response: a pilot study. Radiol Med. 2024 May;129(5):712-726. doi: 10.1007/s11547-024-01811-0. Epub 2024 Mar 27.

    PMID: 38538828BACKGROUND
  • Pan Y, Lei X, Zhang Y. Association predictions of genomics, proteinomics, transcriptomics, microbiome, metabolomics, pathomics, radiomics, drug, symptoms, environment factor, and disease networks: A comprehensive approach. Med Res Rev. 2022 Jan;42(1):441-461. doi: 10.1002/med.21847. Epub 2021 Aug 4.

    PMID: 34346083BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

September 24, 2024

First Posted

September 26, 2024

Study Start

September 1, 2024

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

September 27, 2024

Record last verified: 2024-09

Locations