Clinical trial · Interventional
Determining Minimal Residual Disease Using ctDNA Deep Sequencing
Determination of Minimal Residual Disease by Deep ctDNA Sequencing.
NCT07660627CI-TRIAL-00115780CIT-SEQrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Preoperative neoadjuvant chemotherapy is the standard treatment for locally advanced gastrointestinal tumours. However, not all patients respond to preoperative treatment. Early identification of progression during neoadjuvant chemotherapy or diagnosis of early disease relapse during adjuvant treatment is essential to modify the treatment strategy. The aim of this project is to validate ctDNA as a biomarker of molecular relapse/progression of disease.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Adenocarcinoma | Esophageal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NGS sequencing of mutations selected based on sequencing of primary tumors | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Interventional
- description
- Participants with locally advanced potentially resectable esophageal, gastric, or pancreatic cancer receiving neoadjuvant/perioperative treatment will undergo serial blood sampling for plasma isolation and circulating tumor DNA (ctDNA) analysis. Samples will be collected prior to initiation of neoadjuvant therapy, at the time of surgery, and subsequently at approximately 3-month intervals for 1-2 years after surgery or until disease progression. ctDNA analyses will be performed using a targeted next-generation sequencing (NGS) approach to evaluate longitudinal changes in tumor-specific genomic alterations and their association with treatment response and disease recurrence.
- interventionNames
- Diagnostic Test: NGS sequencing of mutations selected based on sequencing of primary tumors
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- Participants with esophageal, gastric, or pancreatic cancer receiving first-line palliative systemic therapy will undergo serial blood sampling for plasma isolation and ctDNA analysis. Samples will be collected prior to initiation of systemic treatment and subsequently at approximately 3-month intervals during first-line therapy. ctDNA analyses will be performed using the same targeted NGS methodology to assess longitudinal changes in tumor-specific genomic alterations during systemic treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Consent to participate in the study * Patients with esophageal, gastric, or pancreatic cancer, stage 0-2 * Patients with locally advanced, potentially operable disease treated with systemic perioperative chemotherapy or chemoradiotherapy * Patients with metastatic disease treated with first- to third-line palliative systemic therapy Exclusion Criteria: * not specified
References
Publications (0)
Data not yet available
No reference posted for this study.