ctDNA Monitoring After Pancreatic Cancer Surgery (K-4CARE Lite Study)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20+
SponsorChang Gung Memorial Hospital
About this trial
Pancreatic ductal adenocarcinoma (PDAC) carries one of the worst prognoses among solid tumors. Even after curative-intent resection, 70-80% of patients recur within two years. Current post-operative surveillance relies on computed tomography (CT) imaging and the serum tumor marker CA 19-9, but both have limited sensitivity for detecting microscopic residual disease.
This single-center, prospective observational study evaluates the use of the K-4CARE Lite platform-a tumor-informed plus tumor-agnostic circulating tumor DNA (ctDNA) assay with a limit of detection of 0.005%-for dynamic monitoring of minimal residual disease (MRD) in patients with resected PDAC.
Thirty adult patients who have undergone R0 or R1 (margin \<1 mm) resection at Linkou Chang Gung Memorial Hospital will be enrolled over 24 months. Each participant will provide one baseline tumor tissue sample (formalin-fixed paraffin-embedded) and three serial blood samples at three pre-specified study timepoints: Timepoint 1 (Week 4 to Week 10 after surgery, before adjuvant chemotherapy); Timepoint 2 (12 weeks after Timepoint 1, approximately 3 months into adjuvant chemotherapy); and Timepoint 3 (at completion of adjuvant chemotherapy, approximately Month 6 after surgery). A fourth long-term follow-up phase (Timepoint 4) collects results from patient-funded ctDNA testing performed as part of routine care.
The primary outcome is the cumulative MRD detection rate across the three pre-specified post-surgical timepoints (Timepoint 1, Timepoint 2, and Timepoint 3). Secondary outcomes include the association between ctDNA status and disease-free survival (DFS) and overall survival (OS), molecular clearance rate at Timepoint 3, lead time of molecular relapse over imaging, and platform performance. ctDNA results are reported back to the treating physician for reference but do not mandate treatment changes-all clinical decisions remain at the physician's discretion per standard guidelines.
This study aims to generate the prospective evidence base needed to design future ctDNA-guided interventional trials in pancreatic cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 20 years or older
Histologically confirmed pancreatic ductal adenocarcinoma (PDAC), including its histological subtypes
Has undergone curative-intent resection (R0 or R1, defined as margin <1 mm), via pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy
Post-operative pathologic stage at least pT1, with N0 or N1 or higher
Disqualifiers
Post-operative pathologic stage IV (distant metastasis), or R2 resection
Concurrent active primary malignancy (except cured non-melanoma skin cancer or carcinoma in situ within the past 5 years)
Severe post-operative complications precluding initiation of adjuvant chemotherapy within 12 weeks
Receipt of post-operative radiation therapy
Trial population
Adults with histologically confirmed pancreatic ductal adenocarcinoma who underwent R0 or R1 (margin \<1 mm) curative resection at Linkou Chang Gung Memorial Hospital, recruited consecutively from the oncology and general surgical outpatient clinics during their post-operative follow-up. No public advertising or open recruitment used.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
30 Participants
are grouped into 1 trial groupGroup A: Resected PDAC patients undergoing adjuvant chemotherapy
Trial outcomes
Primary outcomes
1
Cumulative Minimal Residual Disease (MRD) Detection Rate Across Three Post-Surgical Timepoints
The proportion of participants with circulating tumor DNA (ctDNA) detected at one or more of the three pre-specified post-surgical surveillance timepoints (Timepoint 1, Timepoint 2, or Timepoint 3). A timepoint is classified as ctDNA-positive if at least one tracking mutation is detected at variant allele frequency above the K-4CARE Lite platform's limit of detection (0.005%). Pancreatic ductal adenocarcinoma is recognized as a moderate-to-low ctDNA shedder, with reported single-timepoint post-resection detection rates of 30-60%; cumulative detection across serial timepoints is hypothesized to improve sensitivity for assay-defined minimal residual disease. Reported as percentage with 95% Wilson confidence interval, with stratified contribution by individual timepoint.
Time frame
From Timepoint 1 (Week 4 to Week 10 after surgery) through Timepoint 3 (approximately Month 6 after surgery, at completion of adjuvant chemotherapy), spanning up to 8 months per participant.Secondary outcomes
1
ctDNA Molecular Clearance Rate at Timepoint 3 (End of Adjuvant Chemotherapy)
Proportion of participants with negative ctDNA result at Timepoint 3 (no tracking mutation detected above the limit of detection), regardless of Timepoint 1 or Timepoint 2 status. Includes both newly cleared participants (positive at Timepoint 1, negative at Timepoint 3) and persistently negative participants.
Time frame
At Timepoint 3, defined as completion of adjuvant chemotherapy (approximately Month 6 after surgery) or earlier termination.2
ctDNA Variant Allele Frequency (VAF) Kinetics During Adjuvant Treatment
For each participant, the slope of the highest variant allele frequency (VAF) of any tracking mutation is computed for up to two intervals: (a) Timepoint 1 to Timepoint 2 (intra-treatment, approximately 12 weeks apart, capturing early response to adjuvant chemotherapy); and (b) Timepoint 1 to Timepoint 3 (full-course, approximately 6-month span, capturing end-of-treatment status). Each interval is categorized as rising (2-fold or greater VAF increase), falling (2-fold or greater decrease), stable (no 2-fold or greater change between detectable values), undetectable-throughout (negative at both timepoints), or new emergence (negative at Timepoint 1, converting to positive at Timepoint 2 or Timepoint 3). Reported per-participant per-interval; aggregate distribution reported as proportions, with sub-analysis comparing Timepoint 1-to-Timepoint 2 versus Timepoint 1-to-Timepoint 3 trajectories. Participants missing one of the two later timepoints contribute only the available interval.
Time frame
From Timepoint 1 (Week 4 to Week 10 after surgery) through Timepoint 3 (approximately Month 6 after surgery, at completion of adjuvant chemotherapy), spanning up to 8 months per participant.3
Disease-Free Survival (DFS)
Time from date of curative surgery to the first radiologically or pathologically confirmed disease recurrence, or death from any cause, whichever occurs first. Estimated by Kaplan-Meier method; participants without recurrence or death are censored at the date of last disease assessment. Stratified analysis comparing ctDNA-positive versus ctDNA-negative participants at Timepoint 1 by log-rank test.
Time frame
From date of surgery up to Month 36 (last enrolled participant followed for at least 12 months after Timepoint 3)4
Overall Survival (OS)
Time from date of curative surgery to death from any cause. Participants alive at the data cut-off are censored at last known alive date. Estimated by Kaplan-Meier method.
Time frame
From date of surgery up to Month 36.Sponsors and contacts
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Source ClinicalTrials.gov
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