Gastric Cancer Clinical Trial
Official title:
Gastric Cancer Prevention: Understanding Precursor Lesions and Risk Factors for Progression to Cancer
| NCT number | NCT06370143 |
| Other study ID # | 24-083 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 11, 2024 |
| Est. completion date | April 11, 2036 |
The purpose of this study is to create a registry of participants with precursor lesions for gastric cancer, including gastric atrophy, intestinal metaplasia, and dysplasia. Normal controls and individuals with gastric cancer for comparison of baseline characteristics will also be enrolled.
| Status | Recruiting |
| Enrollment | 3200 |
| Est. completion date | April 11, 2036 |
| Est. primary completion date | April 11, 2036 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Age = 18 years old - Able to read and understand English - Meet criteria for one of three potentially eligible study populations: - Individuals with gastric atrophy, gastric intestinal metaplasia, or dysplasia (increased risk): Had a previous diagnosis of or have been diagnosed by the investigation team with gastric atrophy, gastric intestinal metaplasia, or dysplasia of the gastric mucosa on pathology review from an endoscopic biopsy - Healthy controls (average risk): Individuals with no history of cancer or gastric precursor lesions undergoing a clinically indicated endoscopy at MSK for workup or dyspepsia or reflux - Gastric cancer cases: Individuals with a known diagnosis of early gastric adenocarcinoma undergoing surgical resection at MSK Exclusion Criteria: - Age < 18 years old - Women who are pregnant (may be enrolled after delivery) - Individuals with a prior history of upper gastrointestinal surgery or a prior upper gastrointestinal cancer diagnosis including esophageal, gastric, or small bowel cancer. (This does not include incidentally diagnosed primary gastric adenocarcinoma identified during study follow up. Individuals diagnosed with gastric carcinoid limited to the stomach will also be included, given their ongoing parallel risk for gastric adenocarcinoma.) - Individuals who have a history of a cancer other than an upper gastrointestinal cancer may be included, if they have no evidence of disease for at least 1 year prior to study enrollment and are not undergoing active treatment for any malignancy at any time throughout the study period. - Have severe comorbidities with expected survival time <2 years or which would prevent them from undergoing routine elective EGD (at the discretion of the patient's provider and the study team) |
| Country | Name | City | State |
|---|---|---|---|
| United States | Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) | Basking Ridge | New Jersey |
| United States | Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity) | Commack | New York |
| United States | Memorial Sloan Kettering Westchester (Limited Protocol Activities) | Harrison | New York |
| United States | Memorial Sloan Kettering Monmouth (All Protocol Activities) | Middletown | New Jersey |
| United States | Memorial Sloan Kettering Bergen (Limited Protocol Activities) | Montvale | New Jersey |
| United States | Memorial Sloan Kettering Cancer Center (All protocol activites) | New York | New York |
| United States | Memorial Sloan Kettering Nassau (Limited Protocol Activites) | Rockville Centre | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Memorial Sloan Kettering Cancer Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Creation of participant registry | The primary objective of this study is to create a registry of individuals with precursor lesions for gastric cancer, including gastric atrophy, intestinal metaplasia, and dysplasia. Normal controls and individuals with gastric cancer for comparison of baseline characteristics will also be enrolled. | Up to 10 years |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05551416 -
The EpiGASTRIC/EDGAR Project: New Strategies for the Early Detection and Prevention of Gastric Cancer
|
||
| Recruiting |
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 |