NCT06326879

Brief Summary

This study aims to investigate the clinical, socioeconomic, behavioral, genetic, and molecular factors characterizing Early Onset Colorectal Cancer (EOCRC) patients compared with Late Onset Colorectal Cancer (LOCRC) patients

Trial Health

77
On Track

Trial Health Score

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

Enrollment
340

participants targeted

Target at P75+ for all trials

Timeline
18mo left

Started Nov 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 Progress63%
Nov 2023Oct 2027

Study Start

First participant enrolled

November 30, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 22, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2027

Last Updated

March 25, 2024

Status Verified

March 1, 2024

Enrollment Period

3.1 years

First QC Date

March 18, 2024

Last Update Submit

March 22, 2024

Conditions

Colorectal Cancer

Keywords

Early Onset Colorectal CancerCancer survivalGenetic and molecular characterization

Outcome Measures

Primary Outcomes (1)

  • Incidence rate ratio of colorectal cancer recurrence

    Incidence rate ratio of 24-month colorectal cancer recurrence- defined as any radiological or endoscopic evidence of local recurrence or distal metastasis after the index surgery in stage I-III patients- between the study cohorts

    24 months after surgery

Secondary Outcomes (4)

  • Correlation between lifestyle and incidence rate of colorectal cancer recurrence

    24 months after surgery

  • Correlation between genetic profile and incidence rate of colorectal cancer recurrence

    24 months after surgery

  • Correlation between molecular profile and incidence rate of colorectal cancer recurrence

    24 months after surgery

  • Correlation between socioeconomic characteristics and incidence rate of colorectal cancer recurrence

    24 months after surgery

Study Arms (2)

Early Onset Colorectal Cancer (EOCRC)

Patients aged less or equal to 49 years old at the time of colorectal cancer diagnosis

Other: No intervention

Late Onset Colorectal Cancer (LOCRC)

Patients aged more or equal to 50 years old at the time of colorectal cancer diagnosis

Other: No intervention

Interventions

No interventionOTHER

Questionnaires compilation and sample collection

Early Onset Colorectal Cancer (EOCRC)Late Onset Colorectal Cancer (LOCRC)

Eligibility Criteria

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

The study will include adult patients with a proven diagnosis of stage I-III colorectal adenocarcinoma, scheduled for elective curative cancer resection.

You may qualify if:

  • Patients with a proven diagnosis of colorectal adenocarcinoma, as reported by the staging histological biopsies.
  • Patients with a preoperative staging I-III.
  • Patients scheduled for elective curative colorectal resection.
  • Patients with rectal cancer who underwent neoadjuvant therapy can be included in the study.
  • Patients able and willing to comply with the protocol requirements (samples' collection and questionnaires' compilation).

You may not qualify if:

  • Patients with metastatic disease at diagnosis.
  • Patients requiring an emergent procedure.
  • Patients undergoing palliative surgery (for example, fecal diversion).
  • Patients with a surgical indication for benign lesions (for example, adenoma or dysplasia).
  • Patients with an intraoperative finding of a lesion other than adenocarcinoma will be withdrawn from the study.
  • Patients with an intraoperative finding of distal metastasis or peritoneal carcinosis will be withdrawn from the study.
  • Patients with a concomitant diagnosis of Inflammatory Bowel Disease.
  • Patients with a known genetic syndrome (for example, Lynch syndrome or Familial Adenomatous Polyposis).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Humanitas Research Hospital

Rozzano, MI, 20089, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum samples collected before the surgical intervention, and six, twelve, and twenty-four months after surgery; fresh tumor sample collected at surgery; Formalin-Fixed Paraffin-Embedded (FFPE) tumor collected at surgery

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Antonino Spinelli, MD, PhD

    IRCCS Huamanitas Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Annalisa Maroli, PhD

CONTACT

02 8224 7776colorapp@humanitas.it

Stefano De Zanet, MS

CONTACT

02 8224 4623colorapp@humanitas.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2024

First Posted

March 22, 2024

Study Start

November 30, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

October 30, 2027

Last Updated

March 25, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)