Gene Alterations for rectum neuroendocrine tumors

JRCT ID: jRCT1040210119

Registered date:26/12/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: neuroendocrine tumore
• Date of first enrollment: 15/03/2022
• Target sample size: 45
• Study type: Observational
• Intervention(s): None

Outcome(s)

• Primary Outcome: the proportion of patients with each type of gene alteration in each cohort by using WES

Secondary Outcome

1.The proportion of patients with each type of gene alteration in each cohort by using CNV analysis, DNA methylation analysis, and RNA expression analysis.
2.Clinical factors at the initial diagnosis in each cohort
3.Clinical factors by type of metastasis (synchronous vs. heterochronous) in Cohort B and Cohort C.
4.Association of different prognosis (Cohorts A, B and C) with the following characteristics
5.The proportion of gene alteration frequencies in Cohort B and Cohort C by type of recurrence (i.e., synchronous and heterochronous).
6.Association of patient survival time with gene alterations and factors

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Mizuno Nobumasa