Infections

All Conditions

Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

Symptoms and General Pathology

Rare Diseases

Pancreatic Neoplasms

Communicable Diseases

Surgical Wound Infection

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Patients undergo the collection of bile samples during standard of care surgery. Samples undergo routine laboratory testing.

Patients undergo the collection of bile samples during standard of care surgery. Samples undergo nanopore sequencing and routine laboratory testing.

Biospecimen Collection

Laboratory Procedure

Nanopore Sequencing

Nicholas D Chia

This early phase I trial evaluates nanopore sequencing for its ability to detect bacteria in bile and prevent surgical site infections in patients undergoing surgery for benign or malignant pancreatic tumors. Surgical site infections are a significant source of poor outcomes in patients undergoing surgery for pancreatic tumors. In most patients who develop this kind of infection, the bacteria identified as causing the infection is also frequently found to be in the bile at time of surgery. Using nanopore sequencing to detect bacteria in the bile of patients undergoing surgery may allow doctors to prevent surgical site infections or treat them sooner or more effectively.

PRIMARY OBJECTIVE:

I. To improve antibiotic stewardship (reducing duration of peri-operative prophylactic antibiotic regimen, reducing administration of broad-spectrum antibiotic) by providing surgical team with rapid Oxford Nanopore (ONT) sequencing data in the early post-operative setting.

SECONDARY OBJECTIVE:

I. To reduce the cost of care through reduction in surgical site infection (SSI) and improved antibiotic stewardship.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo the collection of bile samples during standard of care surgery. Samples undergo routine laboratory testing.

ARM II: Patients undergo the collection of bile samples during standard of care surgery. Samples undergo nanopore sequencing and routine laboratory testing.

After completion of study, patients' medical records are reviewed for 30 days.

"Answers in Hours" A Randomized Controlled Trial Using Microbiome Metagenomics for Bile Duct Cultures

Nanopore Sequencing for Detecting Bacteria in Bile and Preventing Surgical Site Infections in Patients Undergoing Surgery for Benign or Malignant Pancreatic Tumors

For continuous variables, t-test will be performed and for binary variables chi-square or fisher's exact testing will be performed as appropriate. Additional analysis will be performed as necessary to determine differences in study arms.

Mayo Clinic

Carcinoma

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Anti-Infective Agents

All Drugs and Chemicals

Trifluridine

Antimetabolites

Antiviral Agents

Patients will receive either regorafenib by mouth on days 1-21 every 28 day cycle or TAS-102 by mouth twice daily on days 1-5 and 8-12 every 28 day cycle. Patients in this arm will get ctDNA testing and will continue treatment beyond 1st cycle depending on ctDNA results. Beyond that patients will continue treatment in the absence of disease progression or unacceptable toxicity.

Patients will receive either regorafenib by mouth on days 1-21 every 28 day cycle or TAS-102 by mouth twice daily on days 1-5 and 8-12 every 28 day cycle as per standard of care. Patients in this arm will continue treatment in the absence of disease progression or unacceptable toxicity.

Best Practice

Quality-of-Life Assessment

Questionnaire Administration

Regorafenib

Trifluridine and Tipiracil Hydrochloride

Kanwal Raghav

This phase II trial studies circulating cell-free tumor DNA testing to guide treatment with regorafenib or TAS-102 in patients with colorectal cancer that has spread to other areas of the body. Studying samples of blood from patients with colorectal cancer may help doctors understand how well patients respond to treatment. Regorafenib and TAS-102 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known how well ctDNA testing works in guiding treatment with regorafenib and TAS-102 for patients with advanced or metastatic colorectal cancer.

PRIMARY OBJECTIVES:

I. To evaluate the ability of early change in circulating tumor-derived deoxyribonucleic acid (ctDNA) (ctDNA-early dynamic changes \[EDC\] or A ctDNA) during systemic therapy in metastatic colorectal cancer (mCRC) to predict radiographic progression (only standard of care \[SOC\] arm).

II. To evaluate differences in clinically significant treatment-related adverse events (TRAEs) of interest (grade 3/4 toxicity per National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, intolerable grade 2 toxicity or any toxicity requiring dose reduction) between SOC and ctDNA arm.

SECONDARY OBJECTIVES:

I. To evaluate differences in patient-reported outcomes (PROs) between SOC and ctDNA arm.

II. To compare Response Evaluation Criteria in Solid Tumors (RECIST) duration of complete response (DCR) (partial response \[PR\] and stable disease \[SD\]) between SOC and ctDNA arm.

III. To evaluate differences in overall survival (OS) between SOC and ctDNA arm.

IV. To evaluate differences between SOC and ctDNA arm with regards to emergency severity indices (ESIs): Hospitalizations/emergency room visits.

V. To evaluate differences between SOC and ctDNA arm with regards to ESIs: Need for medical interventions (blood transfusions and intravenous \[IV\] hydration).

VI. To evaluate cost-effectiveness associated with both strategies, i.e. SOC strategy and ctDNA strategy in treatment of mCRC.

VII. To compare time to deterioration of Eastern Cooperative Oncology Group (ECOG) performance status (PS) between SOC and ctDNA arms.

VIII. To compare time to deterioration of PROs between SOC and ctDNA arms. IX. To evaluate differences in proportion of patients referred to clinical trial after completion of therapy between SOC and ctDNA arms.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo ctDNA testing and depending on the results receive either regorafenib orally (PO) on days 1-21, trifluridine and tipiracil hydrochloride (TAS-102) PO twice daily (BID) on days 1-5 and 8-12, or regorafenib PO on days 1-21 and TAS-102 PO BID on days 1-5 and 8-12. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive regorafenib or TAS-102 per standard of care. Treatment continues in the event of disease stability or regression as per discretion of treating physician or absence of disease progression.

After completion of study treatment, patients are followed up at 2 weeks and then monthly for up to 18 months.

Circulating Cell-Free Tumor DNA Testing in Guiding Treatment for Patients With Advanced or Metastatic Colorectal Cancer

A Randomized Study Evaluating Tailoring of Advanced/Metastatic Colorectal Cancer (CRC) Therapy Using Circulating Cell-Free Tumor DNA (ctDNA) (TACT-D)

Number of patients with rise in ctDNA level will be compared to Number of patients with progression of disease on scans.

Will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. To compare the proportions of patients who have experienced TRAEs of interest within the first 4 months between the two treatment arms, Fisher's exact test will be used.

Mean PROs scores measured by MDASI-GI scales will be compared between arms

Mean PROs scores measured by PRO-CTCAE scales will be compared between arms

Percentage of patients with PR will be compared between arms

Percentage of patients with SD will be compared between arms

Percentage of patients who present with ESIs \[described as either Hospitalizations/emergency room visits or need for medical interventions (blood transfusions and IV hydration)\] will be compared between arms

Cost measured in US dollars will be compared between arms

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Carcinoma, Ductal

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Bile Duct Cancer

Intrahepatic Cholangiocarcinoma

Hematinics

Gastrointestinal Agents

Herbal and Botanical

Liver Extracts

Pancrelipase

Pancreatin

Cola

Patients undergo fresh tumor tissue collection at the time of surgery. The fresh tumor tissue samples are analyzed for tissue stiffness measurements using optical polarimeter device and cell viability using automated cell counter.

Laboratory Biomarker Analysis

Tissue stiffness and cell viability analysis

Shannon Mumenthaler, Ph.D.

This pilot research trial studies characterization of mechanical tissue properties in patients with pancreatic, liver, or colon cancer. Mechanical properties and stiffness of the cancerous tissue may be correlated with the standard pathology report that describes the stage of the disease.

PRIMARY OBJECTIVES:

I. To determine if our optical polarimeter device is able to measure tissue stiffness across several human cancer types ex vivo.

SECONDARY OBJECTIVES:

I. To describe the inter- and intra-tumor heterogeneity of tissue stiffness. II. To determine if the measurements made by the optical polarimeter device are non-destructive.

TERTIARY OBJECTIVES:

I. Perform multi-variable cross-correlation statistical analysis to determine relationships between: tissue stiffness characteristics, molecular level signatures, and cellular level properties, and if numbers permit, response to treatment.

OUTLINE:

Patients undergo fresh tumor tissue collection at the time of surgery. The fresh tumor tissue samples are analyzed for tissue stiffness measurements using an optical polarimeter device and cell viability using an automated cell counter.

Characterization of Mechanical Tissue Properties in Patients With Pancreatic, Liver, or Colon Cancer

Characterization of Mechanical Tissue Properties in Pancreas, Liver and Colon

A portable optical fiber polarimetric sensor device to measure the Young's modulus in tissue samples will be used.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
"Answers in Hours" A Randomized Controlled Trial Using Microbiome Metagenomics for Bile Duct Cultures	NCT05523154	Benign Pancreat... Malignant Pancr...	Biospecimen Col... Laboratory Proc... Nanopore Sequen...	18 Years -	Mayo Clinic
Circulating Cell-Free Tumor DNA Testing in Guiding Treatment for Patients With Advanced or Metastatic Colorectal Cancer	NCT03844620	Refractory Colo... Stage III Color... Stage IIIA Colo... Stage IIIB Colo... Stage IIIC Colo... Stage IV Colore... Stage IVA Color... Stage IVB Color... Stage IVC Color...	Best Practice Laboratory Proc... Quality-of-Life... Questionnaire A... Regorafenib Trifluridine an...	18 Years -	M.D. Anderson Cancer Center
Characterization of Mechanical Tissue Properties in Patients With Pancreatic, Liver, or Colon Cancer	NCT03137706	Colon Carcinoma Liver and Intra... Pancreatic Carc...	Biospecimen Col... Laboratory Biom... Laboratory Proc...	18 Years -	University of Southern California

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