Clinical trial NCT06314971: Predicting Local and Distant Recurrence in T1 Colorectal Cancer
Official title: Predicting Recurrence After Curative-Intent Resection of T1 Colorectal Cancer With Transcriptomics
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer
Colorectal Neoplasms
Colorectal Adenocarcinoma
Colorectal Cancer Stage I
Colorectal Neoplasms Malignant
Colorectal Cancer Recurrent
Keywords: Endoscopic Submucosal Dissection (ESD)
Endoscopic Submucosal Resection
Surgery
T1
Pathological T1 (pT1)
Messenger RNA
Micro RNA
Formail-Fixed Paraffin Embedded
Tissue
Transcriptomics
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Two cohorts of patients with T1 colorectal cancer

Brief summary: Tumor recurrence significantly affects survival rates following the local resection of submucosal colorectal cancers (T1 CRC). Despite this, there are currently no reliable biomarkers established to predict recurrence in T1 CRC.

This study seeks to improve the prediction of recurrence-free survival in individuals who have survived T1 CRC.

Detailed description: The incidence of invasive submucosal colorectal cancer (T1 CRC) is increasing, likely as a reflection of improved screening and endoscopy use. Current treatment options for T1 CRC focus on less invasive methods (i.e., endoscopic submucosal dissection), and treatment decisions are based on the risk of lymph node metastasis (LNM). Up to 70-80% of T1 CRC patients may undergo surgery, with adjuvant chemotherapy recommended only for those with LNM.

However, current clinical practice guidelines are considered to be overly aggressive and recommend the administration of aggressive treatment to many patients who may be cured with non-invasive therapy alone. This results in the overtreatment of many patients, especially those that are currently defined as 'high-risk' T1 CRC. Existing surveillance methods may not adequately predict the prognosis of T1 CRC, lacking established biomarkers for assessing disease-free survival.

This study seeks to validate tissue-based biomarkers (micro-RNA and messenger RNA) that are associated with tumor recurrence after curative resection. The identification of patients at high risk of recurrence may help in the selection of patients who truly benefit from additional oncologic surgery or adjuvant therapy. Previous research by this group has identified miRNA signatures for detecting postoperative tumor recurrence and metastasis in CRC, highlighting their potential as biomarkers for disease progression.

Eligibility criteria: Inclusion Criteria:

* Stage I, pT1 colorectal cancer (TNM classification, 8th edition).
* Received standard diagnostic, staging, and stage-specific curative-intent resection (endoscopic or surgical, as per local guidelines).
* Confirmed cancer-free survivorship at the time of study inclusion.

Exclusion Criteria:

* Lack of informed consent.
* Induction of neoadjuvant systemic therapy before colorectal cancer resection.
* Synchronous colorectal and non-colorectal cancer diagnosed at or before surgery.

Primary outcomes:
measure: Recurrence-free Survival
timeFrame: Up to 60 months
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
city: Tokushima
country: Japan
facility: Tokushima University
city: Barcelona
country: Spain
facility: Barcelona University
Study officials:
affiliation: City of Hope Medical Center
name: Ajay Goel, PhD
role: PRINCIPAL_INVESTIGATOR
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