Colon Cancer Clinical Trial

Predicting Local and Distant Recurrence in T1 Colorectal Cancer

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.

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Full 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.

View Eligibility Criteria

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.

Study is for people with:

Colon Cancer

Estimated Enrollment:

200

Study ID:

NCT06314971

Recruitment Status:

Recruiting

Sponsor:

City of Hope Medical Center

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There is 1 Location for this study

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City of Hope Medical Center
Duarte California, 91010, United States More Info
Ajay Goel, PhD
Contact
626-218-3452
[email protected]
Takayuki Noma, MD
Principal Investigator
Alessandro Mannucci
Sub-Investigator
Ajay Goel, PhD
Principal Investigator
Tokushima University
Tokushima , , Japan More Info
Mitsuo Shimada, PhD
Contact
[email protected]
Katsuki Miyazaki
Sub-Investigator
Takayuki Noma, MD
Sub-Investigator
Yuma Wada, PhD
Sub-Investigator
Mistuo Shimada, PhD
Principal Investigator
Barcelona University
Barcelona , , Spain More Info
Maria Pellise
Contact
[email protected]
Karmele Saez de Gordoa
Sub-Investigator
María Daca
Sub-Investigator
Francesc Balaguer
Principal Investigator
Maria Pellise
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Estimated Enrollment:

200

Study ID:

NCT06314971

Recruitment Status:

Recruiting

Sponsor:


City of Hope Medical Center

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