Clinical trial · Observational
Changes in Biomarkers From Blood Over Time in Patients With Pancreatic Adenocarcinoma
- 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)
Pancreatic adenocarcinoma (PDAC) is the fourth leading cause of cancer mortality in the United States. The high mortality for these tumors is primarily attributed to the late stage in which most patients are diagnosed, leading to a dismal 5-year survival of 6% for all stages of PDAC. Surgical resection offers the best chance for survival, but most patients only present with symptoms after the tumor has metastasized, and as a result are not operative candidates. This creates a need to both identify patients at an earlier stage while their cancer is still resectable, and predict the aggressiveness of the disease in order to better target treatment. In addition, even patients who receive curative surgery are at a high risk of developing recurrence of disease. Thus, there is also a need to detect recurrence early so appropriate treatment can be provided. As several adjuvant chemotherapeutic regimens are now available, it will be important to identify as soon as possible that the cancer has become refractory to a given therapy. This will allow one to progress to second or third line therapy more quickly while the tumor burden is smaller. This purpose of this study is to identify biomarkers in the blood of patients with PDAC and determine how they can change over time in relation to treatment to assess for any correlation with patient outcomes, response to treatment, recurrence of disease and overall survival. This study will be limited to patients who present to the Johns Hopkins Hospital between January 1, 2015 and December 31, 2018 with PDAC. Blood will be drawn from all consenting patients at the time of initial diagnosis and after treatment. Patients will undergo treatment for their cancer based on personal preference, standard guidelines and discussion with medical, radiation, and surgical oncologists. Patients who undergo surgical resection will also have an additional blood sample collected after resection, and patients who undergo chemotherapy and/or radiation will have an additional blood sample draw at the end of this treatment. A patient could have blood collected at multiple intervals, i.e. a pre-treatment sample, sample post-neoadjuvant chemotherapy/radiation, sample post-surgery, and sample post-adjuvant chemotherapy/radiation. In patients, who have undergone curative resection of PDAC blood samples will be collected till they develop clinical recurrence of disease. For the first 2 years following surgery samples will be collected every 3-4 months. Beyond that the investigators will collect samples every 6 months for the next two years. For all patients found to be alive and disease free beyond 4 years after surgery samples will be collected once every year. These patients will be followed to determine disease-free and overall survival. With this study, the investigators aim to assess the potential utility of blood biomarkers over time for pancreatic tumors which will help both with early detection of disease and also recurrence of disease after surgery. Biomarkers identified would have the potential to create a new method for early diagnosis of patients with PDAC, predict overall survival, response to treatment, or risk of metastatic spread, and predict recurrence of disease, all of which has the potential to drastically improve outcomes for this deadly 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 |
|---|---|---|---|
| Biological Markers | — | UNRESOLVED | — |
| Neoplastic Cells, Circulating | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention/exposures | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Chemotherapy Group
- description
- This cohort includes patients who will receive chemotherapy at any stage or their treatment.
- interventionNames
- Other: No intervention/exposures
- label
- Radiation therapy Group
- description
- This cohort includes patients who will receive radiation therapy at any stage or their treatment.
- interventionNames
- Other: No intervention/exposures
- label
- Surgical resection of the primary tumor
- description
- This cohort includes patients who will undergo resection of the primary tumor.
- interventionNames
- Other: No intervention/exposures
Primary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who present to the Johns Hopkins Hospital for treatment with a diagnosis of pancreatic adenocarcinoma. Exclusion Criteria: * Patients with non-primary pancreas tumors, pancreatic neuroendocrine tumors, or benign pancreatic masses * Patients who have already undergone cancer treatment of any kind at another institution.
References
Publications (2)
- DERIVEDJaved AA, Floortje van Oosten A, Habib JR, Hasanain A, Kinny-Koster B, Gemenetzis G, Groot VP, Ding D, Cameron JL, Lafaro KJ, Burns WR, Burkhart RA, Yu J, He J, Wolfgang CL. A Delay in Adjuvant Therapy Is Associated With Worse Prognosis Only in Patients With Transitional Circulating Tumor Cells After Resection of Pancreatic Ductal Adenocarcinoma. Ann Surg. 2023 Jun 1;277(6):866-872. doi: 10.1097/SLA.0000000000005710. Epub 2022 Sep 15. PMID 36111839
- DERIVEDGemenetzis G, Groot VP, Yu J, Ding D, Teinor JA, Javed AA, Wood LD, Burkhart RA, Cameron JL, Makary MA, Weiss MJ, He J, Wolfgang CL. Circulating Tumor Cells Dynamics in Pancreatic Adenocarcinoma Correlate With Disease Status: Results of the Prospective CLUSTER Study. Ann Surg. 2018 Sep;268(3):408-420. doi: 10.1097/SLA.0000000000002925. PMID 30080739