Changes in Biomarkers From Blood Over Time in Patients With Pancreatic Adenocarcinoma

NCT02974764 | Completed

• 1 other identifier: IRB00092443
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Neoplastic Cells, Circulating; Pancreatic Cancer; Biological Markers

Outcome Measures

Primary Outcomes (7)

• Changes in Circulating Tumor Cells (CTCs) numbers after application of chemotherapy in patients with pancreatic adenocarcinoma.

  January 1st 2015 - December 31st 2018

• Changes in Circulating Tumor Cells (CTCs) numbers after application of radiation therapy in patients with pancreatic adenocarcinoma.

  January 1st 2015 - December 31st 2018

• Changes in Circulating Tumor Cells (CTCs) numbers after surgical resection of the primary tumor in patients with pancreatic adenocarcinoma.

  January 1st 2015 - December 31st 2018

• Changes in Circulating Tumor Cells (CTCs) protein expression after application of chemotherapy in patients with pancreatic adenocarcinoma.

  January 1st 2015 - December 31st 2018

• Changes in Circulating Tumor Cells (CTCs) protein expression after application of radiation therapy in patients with pancreatic adenocarcinoma.

  January 1st 2015 - December 31st 2018

• Changes in Circulating Tumor Cells (CTCs) protein expression after surgical resection of the primary tumor in patients with pancreatic adenocarcinoma.

  January 1st 2015 - December 31st 2018

• Driver gene mutations detection in CTCs in patients with pancreatic adenocarcinoma.

  January 1st 2015 - December 31st 2018

Secondary Outcomes (2)

• Changes in Circulating Tumor Cells (CTCs) numbers in response to disease progression from localized to metastatic disease.

  January 1st 2015 - December 31st 2018

• Changes in Circulating Tumor Cells (CTCs) protein expression in response to disease progression from localized to metastatic disease.

  January 1st 2015 - December 31st 2018

Study Arms (3)

Chemotherapy Group

This cohort includes patients who will receive chemotherapy at any stage or their treatment.

Other: No intervention/exposures

Radiation therapy Group

This cohort includes patients who will receive radiation therapy at any stage or their treatment.

Other: No intervention/exposures

Surgical resection of the primary tumor

This cohort includes patients who will undergo resection of the primary tumor.

Other: No intervention/exposures

Interventions

No intervention/exposures OTHER

Chemotherapy Group; Radiation therapy Group; Surgical resection of the primary tumor

Eligibility Criteria

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

Study Population

All patients who present to the Johns Hopkins Hospital with a pancreatic adenocarcinoma for evaluation of treatment by chemotherapy, radiation therapy, and/or surgery will be approached to participate in this study, but only those who consent to the study will be included.

You may qualify if:

• Patients who present to the Johns Hopkins Hospital for treatment with a diagnosis of pancreatic adenocarcinoma.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Related Publications (2)

• Javed 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 DERIVED

• Gemenetzis 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 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample draw (50 ml or 3-4 tablespoons)

MeSH Terms

Conditions

Neoplastic Cells, Circulating; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Christopher L Wolfgang, MD PhD

  Johns Hopkins University School of Medicine - Department of Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2016
• First Posted: November 28, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 24, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)