NCT04600518

Brief Summary

A retrospective, multi-center, single-blind, pivotal trial to assess clinical equivalence with stage II and III advanced gastric cancer based on the 6th and 8th of the AJCC

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,047

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 7, 2020

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 23, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2023

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2023

Completed
Last Updated

July 22, 2024

Status Verified

July 1, 2023

Enrollment Period

2.7 years

First QC Date

October 19, 2020

Last Update Submit

July 19, 2024

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (3)

  • Differences in prognosis

    Differences in prognosis between Low risk group and High risk group (AJCC 8th, Advanced gastric cancer stage II and III)

    5 years after the date of surgery for patients in Low risk group and High risk group

  • Comparability of prognostic stratification

    Comparability of prognostic stratification with stage II and III advanced gastric cancer based on the 6th and 8th of the AJCC

    5 years after the date of surgery for patients in Low risk group and High risk group

  • Prognostic equivalence

    Prognostic equivalence between surgery only group and adjuvant chemotherapy group in Low risk group

    5 years after the date of surgery for patients in surgery only group and adjuvant chemotherapy group in Low risk group

Secondary Outcomes (1)

  • Multivariate analysis

    5 years after the date of surgery for patients with stage II-III advanced gastric cancer (8th of the AJCC)

Study Arms (1)

SPRINT cohort

stage II and III advanced gastric cancer patients based on the 6th and 8th of the AJCC

Device: nProfiler I Stomach Cancer Assay Kit

Interventions

nProfiler I Stomach Cancer Assay KitDEVICE

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

SPRINT cohort

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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
  • Postoperative patients with gastric cancer invading the submucosal layer and having 3 or more lymph nodes metastasis or who with gastric cancer infiltration of muscularis propria and lymph node metastasis (stage II and III advanced gastric cancer patients, 8th of the AJCC)
  • Patients who have not received neoadjuvant chemotherapy and radiotherapy
  • Patients with pathological record and clinical information after surgery from archived FFPE(formalin-fixed paraffin-embedded) samples between 2005 and 2010
  • Patients who have not been included in discovery clinical trial and confirmatory clinical trial
  • 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
  • Sample criteria
  • The 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
  • Postoperative patients with gastric cancer invading the mucosa and submucosal layer and having less than 3 lymph nodes metastasis or who with gastric cancer infiltration of muscularis propria without lymph node metastasis (stage II and III advanced gastric cancer patients, 8th of the AJCC)
  • Patients who have received neoadjuvant chemotherapy or radiotherapy
  • Patients without pathological record and clinical information after surgery from archived FFPE samples between 2005 and 2010
  • Patients who have been included in discovery clinical trial and confirmatory clinical trial
  • Patients with residual tumors after surgery
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novomics. Co., Ltd.

Seoul, 07217, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

FFPE samples

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Young-Woo Kim, MD., Ph.D.

    National Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2020

First Posted

October 23, 2020

Study Start

October 7, 2020

Primary Completion

June 18, 2023

Study Completion

June 22, 2023

Last Updated

July 22, 2024

Record last verified: 2023-07

Locations

KR(1)