Clinical Trials Logo
  1. Home
  2. Gastric Cancer
  3. NCT04576858
  4. Details
NCT04576858 Clinical Trial

Clinical Utility of Circulating Tumor DNA in Gastro-Esophageal Cancer

Gastric Cancer Clinical Trial

— CURE  

Official title:
Clinical Utility of Circulating Tumor DNA in Gastro-Esophageal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04576858
Other study ID # CURE
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 3, 2020
Est. completion date July 2025

Study information
Verified date September 2020
Source Rigshospitalet, Denmark
Contact Morten Mau-Sørensen, MD, PhD
Phone 35450879
Email mms@rh.regionh.dk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a prospective cohort study designed to evaluate the treatment effect as well as predictive and prognostic factors with special emphasis on the clinical utility of ctDNA in plasma in patients with gastroesophageal cancer. Patients with gastroesophageal cancer are included in 5 separate cohorts scheduled for

- Surgical resection + perioperative chemotherapy (cohort 1)

- Neoadjuvant chemoradiotherapy followed by surgical resection (cohort 2)

- Definitive chemoradiotherapy with curative intent (cohort 3)

- Systemic therapy with the intent to prolong survival (cohort 4)

- Palliative treatment without the use of chemotherapy (cohort 5)

Recruitment information / eligibility
Status Recruiting
Enrollment 1950
Est. completion date July 2025
Est. primary completion date February 2025
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

Gastroesophageal cancer Age 18 years or older Able to understand and sign written informed consent

Exclusion Criteria:

Patients not providing informed consent

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Circulating tumor DNA
Measurement of circulating tumor DNA from plasma over a period of 2 years.

Locations
Country Name City State
Denmark Rigshospitalet Copenhagen

Sponsors (1)
Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time to recurrence 1 year
Secondary Time to progression 1 year
Secondary Overall survival 5 year
Secondary Response rate RECIST 1.1 through study completion, an average of 1 year
Secondary Response duration RECIST 1.1 through study completion, an average of 1 year
See also
  Status Clinical Trial Phase
Recruiting NCT05551416 - The EpiGASTRIC/EDGAR Project: New Strategies for the Early Detection and Prevention of Gastric Cancer
Completed NCT05518929 - Hypoxia During Gastroenterological Endoscope Procedures Sedated With Ciprofol In Overweight Or Obesity Patients Phase 4
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT03219593 - Apatinib as the First-Line Therapy in Elderly Locally Advanced or Metastatic Gastric Cancer Phase 2
Recruiting NCT05489211 - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) Phase 2
Recruiting NCT05536102 - The Effectiveness and Safety of XELOX and Tislelizumab + PLD for Resectable Gastric Cancer (LidingStudy) Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Recruiting NCT06010862 - Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors Phase 1
Recruiting NCT05415098 - Study of Safety, Pharmacokinetic and Efficacy of APG-5918 in Advanced Solid Tumors or Lymphomas Phase 1
Active, not recruiting NCT04082364 - Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer Phase 2/Phase 3
Withdrawn NCT03766607 - Trastuzumab Beyond Progression in HER2 Positive Metastatic Gastric Cancer Phase 2
Recruiting NCT04118114 - Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors Phase 2
Completed NCT01924533 - Efficacy and Safety Study of Olaparib in Combination With Paclitaxel to Treat Advanced Gastric Cancer. Phase 3
Terminated NCT01641939 - A Study of Trastuzumab Emtansine Versus Taxane in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Gastric Cancer Phase 2/Phase 3
Recruiting NCT05107674 - A Study of NX-1607 in Adults With Advanced Malignancies Phase 1
Active, not recruiting NCT04908813 - Study of HLX22 in Combanition With Trastuzumab and Chemotherapy Versus Placebo in Combination With Trastuzumab and Chemotherapy for Treatment of Locally Advanced or Metastatic Gastric Cancer Phase 2
Active, not recruiting NCT04249739 - Pembrolizumab + Capecitabine／Oxaliplatin (CapeOx) -HER2 Nagative and Pembrolizumab + Trastuzumab + Cisplatin/Capecitabine HER2 Positive Phase 2
Recruiting NCT05514158 - To Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Disitamab Vedotin Combined With RC98 in the Treatment of Subjects With HER2-expressing Locally Advanced or Metastatic Gastric Cancer (Including AEG) Phase 1
Recruiting NCT04931654 - A Study to Assess the Safety and Efficacy of AZD7789 in Participants With Advanced or Metastatic Solid Cancer Phase 1/Phase 2
Recruiting NCT03175224 - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Phase 2