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NCT04487717Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 17 Dec 2024

Brief summary (registry, in English)

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

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
581 (actual)
First submitted
22 Jul 2020
Start date
29 Jul 2020
Primary completion date
31 Oct 2029
Lead sponsor
Novomics. Co., Ltd.
NCT number
NCT04487717

What you commit to

  • Study type: Observational
  • Participants enrolled: 581
  • From 29 Jul 2020 to the primary completion date, 31 Oct 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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)

Other

  • 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

Who the study is looking for

  • 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.

Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Novomics
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.