Clinical trial · Observational
Predicting Disease Progression and/or Recurrence in Cancer
Tumor Markers, Liquid Biopsies, and Patient Reported Outcomes in Metastatic Colorectal, Pancreas, Biliary, and Esophagogastric Cancers
NCT04776837CI-TRIAL-00111689completedClinicalTrials.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)
This is a prospective study addressing the challenge of predicting disease progression and/or recurrence in patients diagnosed with metastatic colorectal, pancreatobiliary, or esophagogastric cancer that are receiving anti-cancer therapy.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract Cancer | Malignant Biliary Tract Neoplasm | ALIAS | 0.90 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Disease Progression | — | UNRESOLVED | — |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Patient Reported Outcome Measures | — | UNRESOLVED | — |
| Survival Analysis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Observational Cohort | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Main Cohort
- description
- * Patient-reported outcomes (e.g. symptoms, quality of life) and biomarkers compare to standard of care clinical assessments such as imaging and tumor markers in predicting the clinical outcomes (e.g. disease progression and survival) * Prior to starting anti-cancer therapy and at subsequent designated visits (every one month) * Collections include: * Blood sample * Questionnaires quality of life, mood, and symptoms * Tissue may be obtained for next-generation sequencing.
- interventionNames
- Behavioral: Observational Cohort
Primary outcomes (1)
- measure
- Treatment Response at 1st Scan
- timeFrame
- 6 months
- description
- The primary outcome is treatment response (RECIST 1.1) at first scan (\>1 month post-treatment start). Both response status (PR vs SD or PD \[including death\]) and clinical benefit status (PR or SD vs PD \[including death\]) will be examined. Primary analyses will compare one month change from baseline in tumor markers, MAF of the selected clonal mutation in ctDNA, and PROs (symptoms, mood, and QOL) individually and a composite score in predicting response and clinical benefit (CB) at first scan.
Secondary outcomes (11)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
* Inclusion Criteria: * Patients must have histologically confirmed colorectal, pancreatobiliary, or esophagogastric cancer. * Diagnosed with metastatic disease * Age \> 18 years. * Patients must be starting new line of anti-cancer therapy. * Patient must be English-speaking. * Exclusion Criteria * Unwilling or unable to participate in the study * Non-metastatic disease * Not starting new anti-cancer treatment * Cognitive issues interfering with ability to participate. * Active, unstable, untreated serious mental illness interfering with ability to participate. * Patient does not speak English.
References
Publications (1)
- RESULTJarnagin JX, Saraf A, Baiev I, Chi G, van Seventer EE, Mojtahed A, Allen JN, Clark JW, Blaszkowsky L, Giantonio BJ, Weekes CD, Klempner SJ, Franses JW, Roeland EJ, Goyal L, Siravegna G, Horick N, Corcoran RB, Nipp RD, Parikh AR. Patient-Reported Outcomes, Tumor Markers, and Survival Outcomes in Advanced GI Cancer. JAMA Netw Open. 2023 Nov 1;6(11):e2343512. doi: 10.1001/jamanetworkopen.2023.43512. PMID 37976066