Gene Alterations for rectum neuroendocrine tumors

Not Applicable

• Conditions: neuroendocrine tumore; NET NEN GI-NET

• Registration Number: JPRN-jRCT1040210119
• Lead Sponsor: Mizuno Nobumasa

Brief Summary

Rectal NETs with unfavorable outcomes (cohorts B and C) had unique genomic and epigenetic alterations, which might be used as a prognostic marker for risk stratification of rectal NETs.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-26
• Last Update Posted: 22 January 2024
• Results First Posted: 2024-06-30

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

1.Provision of written informed consent prior to any study related procedures.
2.Diagnosed to be suffering from advanced rectal NET (World Health Organization Grade 1 or 2, up to 20% Ki-67).
3.Male or female, aged 18 or older.
4.An archival tissue sample (at the time of initial diagnosis before intervention) of the primary tumor by endoscopic biopsy must be available for molecular testing. If the sample volume is insufficient, surgical specimens or specimens from metastases must be available.
5.Cohort A
T2N1M0 or higher at the first diagnosis (Stage III).
Recurrence-free survival of 5 years or more from initial surgical treatment (at the time of enrollment).
No distant metastases (including regional lymph node metastases).
6.Cohort B
Distant metastases (excluding regional lymph node metastases).
Survival period of 3 years or more after distant metastasis diagnosis (at the time of data cutoff).
7.Cohort C
Distant metastases (excluding regional lymph node metastases).
Survival period of less than 3 years from distant metastasis diagnosis (at the time of data cutoff).
Patients who died due to reason current tumor.

Exclusion Criteria

1.Patients diagnosed with NEC and MiNEN.
2.Neuroendocrine tumors that do not originate in the rectum.
3.Patients with NET G3 (Ki-67 > 20).
4.Patients who received peptide receptor radionuclide therapy (PRRT).
5.Patients who died due to reasons other than current tumor reason (e.g. side effects of drugs, suicide).
6.Tissue sample that collected after drug intervention for NET.
7.Cohort A
Patients who have only undergone endoscopic resection (endoscopic sub-mucosal dissection (ESD), endoscopic mucosal resection (EMR) etc.)
Patients who have record of recurrence or death.

Study & Design

• Study Type: Observational
• Study Design: Not specified