ctDNA Monitoring After Pancreatic Cancer Surgery (K-4CARE Lite Study)

NCT07597252 | Not Yet Recruiting

• 2 other identifiers: K4CARE-Lite-PDAC-2026Chang Gung Memorial Hospital
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

NGS Monitor MRD; Pancreatic Ductal Adenocarcinoma (PDAC)

Keywords

pancreatic cancer; circulating tumor DNA; minimal residual disease; tumor-informed sequencing; adjuvant chemotherapy; liquid biopsy; K-4CARE Lite

Outcome Measures

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.

  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 (5)

• ctDNA Molecular Clearance Rate at Timepoint 3 (End of Adjuvant Chemotherapy)

  At Timepoint 3, defined as completion of adjuvant chemotherapy (approximately Month 6 after surgery) or earlier termination.

• ctDNA Variant Allele Frequency (VAF) Kinetics During Adjuvant Treatment

  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.

• Disease-Free Survival (DFS)

  From date of surgery up to Month 36 (last enrolled participant followed for at least 12 months after Timepoint 3)

• Overall Survival (OS)

  From date of surgery up to Month 36.

• Lead Time of Molecular Relapse Over Imaging

  From Timepoint 1 (Week 4 to Week 10 after surgery) to end of follow-up, up to Month 36

Study Arms (1)

Resected PDAC patients undergoing adjuvant chemotherapy

Adults with histologically confirmed pancreatic ductal adenocarcinoma who have undergone R0 or R1 (margin \<1 mm) curative resection at Linkou Chang Gung Memorial Hospital, with intent to receive adjuvant chemotherapy. All participants follow the same ctDNA monitoring schedule (Timepoint 1, Timepoint 2, and Timepoint 3 are mandatory; Timepoint 4 is passive data collection from self-funded testing).

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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
• Computed tomography (CT) or magnetic resonance imaging (MRI) within 4 weeks before enrollment confirming no evidence of residual tumor and no distant metastasis
• Intent to receive adjuvant chemotherapy
• Sufficient surgical FFPE tumor tissue available for genomic sequencing
• Able to understand and provide signed informed consent
• Patients with or without prior neoadjuvant chemotherapy are both eligible

You may not qualify if:

• 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
• Known hematologic disease or myeloproliferative disorder that may significantly affect ctDNA assay accuracy
• Pregnant or breastfeeding women
• Unable to comply with the protocol-specified blood draw schedule

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Linkou Chang Gung Memorial Hospital

Taoyuan, Taoyuan, 333, Taiwan

Location

Related Publications (8)

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  PMID: 35809752 BACKGROUND

• Conroy T, Hammel P, Hebbar M, Ben Abdelghani M, Wei AC, Raoul JL, Chone L, Francois E, Artru P, Biagi JJ, Lecomte T, Assenat E, Faroux R, Ychou M, Volet J, Sauvanet A, Breysacher G, Di Fiore F, Cripps C, Kavan P, Texereau P, Bouhier-Leporrier K, Khemissa-Akouz F, Legoux JL, Juzyna B, Gourgou S, O'Callaghan CJ, Jouffroy-Zeller C, Rat P, Malka D, Castan F, Bachet JB; Canadian Cancer Trials Group and the Unicancer-GI-PRODIGE Group. FOLFIRINOX or Gemcitabine as Adjuvant Therapy for Pancreatic Cancer. N Engl J Med. 2018 Dec 20;379(25):2395-2406. doi: 10.1056/NEJMoa1809775.

  PMID: 30575490 BACKGROUND

• Kobayashi S, Nakamura Y, Hashimoto T, Bando H, Oki E, Karasaki T, Horinouchi H, Ozaki Y, Iwata H, Kato T, Miyake H, Ohba A, Ikeda M, Chiyoda T, Hasegawa K, Fujisawa T, Matsuura K, Namikawa K, Yajima S, Yoshino T, Hasegawa K. Japan society of clinical oncology position paper on appropriate clinical use of molecular residual disease (MRD) testing. Int J Clin Oncol. 2025 Apr;30(4):605-654. doi: 10.1007/s10147-024-02683-0. Epub 2025 Feb 7.

  PMID: 39920551 BACKGROUND

• Borges FC, Pinto MS, Borges MF, Joao AA, Francisco E, Sousa M, Aral M, Oliveira V, Cunha JF, Mehrabi A, Berchtold C, Goncalves G, Bailey P, Buchler MW. The Role of Circulating Tumor DNA in Surgical Management of Pancreatic Cancer: Systematic Review and Meta-analysis. Ann Surg. 2026 Feb 16. doi: 10.1097/SLA.0000000000007036. Online ahead of print.

  PMID: 41696920 BACKGROUND

• Bernard V, Kim DU, San Lucas FA, Castillo J, Allenson K, Mulu FC, Stephens BM, Huang J, Semaan A, Guerrero PA, Kamyabi N, Zhao J, Hurd MW, Koay EJ, Taniguchi CM, Herman JM, Javle M, Wolff R, Katz M, Varadhachary G, Maitra A, Alvarez HA. Circulating Nucleic Acids Are Associated With Outcomes of Patients With Pancreatic Cancer. Gastroenterology. 2019 Jan;156(1):108-118.e4. doi: 10.1053/j.gastro.2018.09.022. Epub 2018 Sep 19.

  PMID: 30240661 BACKGROUND

• Pietrasz D, Pecuchet N, Garlan F, Didelot A, Dubreuil O, Doat S, Imbert-Bismut F, Karoui M, Vaillant JC, Taly V, Laurent-Puig P, Bachet JB. Plasma Circulating Tumor DNA in Pancreatic Cancer Patients Is a Prognostic Marker. Clin Cancer Res. 2017 Jan 1;23(1):116-123. doi: 10.1158/1078-0432.CCR-16-0806. Epub 2016 Dec 19.

  PMID: 27993964 BACKGROUND

• Lee B, Lipton L, Cohen J, Tie J, Javed AA, Li L, Goldstein D, Burge M, Cooray P, Nagrial A, Tebbutt NC, Thomson B, Nikfarjam M, Harris M, Haydon A, Lawrence B, Tai DWM, Simons K, Lennon AM, Wolfgang CL, Tomasetti C, Papadopoulos N, Kinzler KW, Vogelstein B, Gibbs P. Circulating tumor DNA as a potential marker of adjuvant chemotherapy benefit following surgery for localized pancreatic cancer. Ann Oncol. 2019 Sep 1;30(9):1472-1478. doi: 10.1093/annonc/mdz200.

  PMID: 31250894 BACKGROUND

• Groot VP, Mosier S, Javed AA, Teinor JA, Gemenetzis G, Ding D, Haley LM, Yu J, Burkhart RA, Hasanain A, Debeljak M, Kamiyama H, Narang A, Laheru DA, Zheng L, Lin MT, Gocke CD, Fishman EK, Hruban RH, Goggins MG, Molenaar IQ, Cameron JL, Weiss MJ, Velculescu VE, He J, Wolfgang CL, Eshleman JR. Circulating Tumor DNA as a Clinical Test in Resected Pancreatic Cancer. Clin Cancer Res. 2019 Aug 15;25(16):4973-4984. doi: 10.1158/1078-0432.CCR-19-0197. Epub 2019 May 29.

  PMID: 31142500 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Formalin-fixed paraffin-embedded (FFPE) tumor tissue collected at baseline, and whole blood (20 mL per timepoint at Timepoint 1, Timepoint 2, and Timepoint 3) with buffy coat. Plasma and tissue DNA are extracted for next-generation sequencing on the K-4CARE Lite platform.

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasm, Residual

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Wen-Kuan Huang, MD,PhD

CONTACT

886-3-3281200; medfox0924@cgmh.org.tw

Chun-Nan Yeh, MD

CONTACT

886-3-3281200; ycn@cgmh.org.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician, Division of Hematology-Oncology

Study Record Dates

• First Submitted: May 9, 2026
• First Posted: May 19, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2029
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)