Prospective Assessment of nProfiler® 1 on Prognosis and Chemotherapy Response for Gastric Cancer

NCT04487717 | Active Not Recruiting DMC

• 1 other identifier: NM-CTP-05
• Study Type: observational
• Target: 581
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective assessment of nProfiler® 1 predictive test on prognosis and chemotherapy response for resectable gastric cancer

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Prognostic group's 5-yr Overall Survival(OS) rate

  High risk and low risk group's 5-yr Overall Survival(OS) rate

  5 years after last registered patient

Secondary Outcomes (2)

• Prognostic group's 3-yr Disease Free Survival(DFS) rate

  3 years after last registered patient

• Subgroup analysis

  3, 5 years after last registered patient

Study Arms (1)

PREDICT cohort

Patients with pathologic stage II, III advanced gastric cancer

Device: nProfiler I Stomach Cancer Assay Kit

Interventions

nProfiler I Stomach Cancer Assay Kit DEVICE

nProfiler I Stomach Cancer Assay Kit (Novomics Co., Korea)

PREDICT cohort

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

19 years or older patients with stage II, III gastric adenocarcinoma

You may qualify if:

• Sample providers criteria
• Male and female adult patients aged 19 years or over
• Patients with histologically confirmed gastric adenocarcinoma
• Patients with histologically confirmed stage Ⅱ or Ⅲ
• Patients who have undergone radical gastrectomy
• Patients who have not received neoadjuvant chemotherapy and radiotherapy
• Patients who have undergone a radical gastrectomy and who show no evidence of residual tumors as observed with the unaided eye or through a microscope
• Patients who have signed a written consent of the study and signed a human derived research agreement (Form 34)
• Sample criteria
• The formalin-fixed paraffin-embedded (FFPE) tumor specimens in storage have a tumor amount of at least 20% and therefore can be tested.
• The quantity (not less than 400ng) and quality (A260/280 of not less than 1.8) of RNA are sufficient for analysis.

You may not qualify if:

• Sample providers criteria
• Male and female patients aged less than 19 years
• Patients with histologically not confirmed gastric adenocarcinoma
• Patients with histologically confirmed stage Ⅰ or Ⅳ
• Patients who have not undergone radical gastrectomy
• Patients who have received neoadjuvant chemotherapy or radiotherapy
• Patients with distant or peritoneal metastasis at the time of surgery or residual tumors after surgery
• Patients who have not signed the study's written consent and human derived research agreement (Form 34)
• Sample criteria
• The FFPE tumor specimens in storage have a tumor amount of less than 20% and therefore cannot be tested
• The quantity and quality of RNA are not sufficient for analysis

Sponsors & Collaborators

• Novomics. Co., Ltd.: lead

Study Sites (1)

Novomics

Seoul, 07217, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

tissue

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Young-Woo Kim, MD., Ph.D.

  National Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 27, 2020
• Study Start: July 29, 2020
• Primary Completion (Estimated): October 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)