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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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This is a clinical trial to compare two needles used in biopsy techniques to acquire tissue from pancreatic cancer. The hypothesis is that the tissue yield, as measured by tumor DNA and cellular material is superior for Flexible Needle Biopsy (FNB) compared with conventional Fine Needle Aspiration (FNA). Specifically, FNB will increase the proportion of cases in which sufficient DNA is obtained to allow genomic profiling and whole exome sequencing.
This is a single-blinded randomized controlled trial with paired evaluation of conventional FNA needle versus FNB needle stratified by lesion location (pancreas head tumor versus pancreas body/tail). A minimum of 4 passes ( 2 with each needle) will be performed from all the lesions. After each pass of needle, the on-site cytopathologists will evaluate the adequacy and the degree of the pathological changes in the obtained material. Based on the information provided by the onsite cytopathologists, the endosonographer will repeat the FNA until enough histological material is obtained to confirm a diagnosis. Patients will be assessed immediately after procedure and during the first 30 days with a follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FNB first, then FNA | Active Comparator | In an endoscopic ultrasound-guided procedure, Shark Core Fine Needle Biopsy (FNB) will be performed first, followed by Fine Needle Aspiration (FNA). |
|
| FNA first, then FNB | Active Comparator | In an endoscopic ultrasound-guided procedure, Fine Needle Aspiration (FNA) will be performed first, followed by Shark Core Fine Needle Biopsy (FNB). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fine Needle Biopsy (FNB) | Device | The Shark Core FNB is an FDA approved device for sampling of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses. FNB will be performed by 22 gauge for pancreas head and by 19 gauge for all the other sites. |
| Measure | Description | Time Frame |
|---|---|---|
| Total DNA Yield of Adenocarcinoma | Total quantity of DNA obtained from first needle pass of adenocarcinoma, measured in ng/µL. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Passes Needed to Obtain Adequate Tissue Sample for Cytology/Histology Diagnosis | The total number of passes required to obtain adequate tissue sample for cytology/histology processing and interpretation. | Baseline |
| Core Tissue Length |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael B. Wallace, MD, MPH | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Jacksonville | Florida | 32224 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | FNB First, Then FNA | In an endoscopic ultrasound-guided procedure, Shark Core Fine Needle Biopsy (FNB) will be performed first, followed by Fine Needle Aspiration (FNA). Fine Needle Biopsy (FNB): The Shark Core FNB is an FDA approved device for sampling of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses. FNB will be performed by 22 gauge for pancreas head and by 19 gauge for all the other sites. Fine Needle Aspiration (FNA): Fine needle aspiration is a type of biopsy procedure. In fine needle aspiration, a thin needle is inserted into an area of abnormal-appearing tissue or body fluid, and histological material is obtained. FNA will be performed with a standard 25g needle in the usual fashion using back and forth passes for 30 seconds. |
| FG001 | FNA First, Then FNB | In an endoscopic ultrasound-guided procedure, Fine Needle Aspiration (FNA) will be performed first, followed by Shark Core Fine Needle Biopsy (FNB). Fine Needle Biopsy (FNB): The Shark Core FNB is an FDA approved device for sampling of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses. FNB will be performed by 22 gauge for pancreas head and by 19 gauge for all the other sites. Fine Needle Aspiration (FNA): Fine needle aspiration is a type of biopsy procedure. In fine needle aspiration, a thin needle is inserted into an area of abnormal-appearing tissue or body fluid, and histological material is obtained. FNA will be performed with a standard 25g needle in the usual fashion using back and forth passes for 30 seconds. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | FNB First, Then FNA | In an endoscopic ultrasound-guided procedure, Shark Core Fine Needle Biopsy (FNB) will be performed first, followed by Fine Needle Aspiration (FNA). Fine Needle Biopsy (FNB): The Shark Core FNB is an FDA approved device for sampling of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses. FNB will be performed by 22 gauge for pancreas head and by 19 gauge for all the other sites. Fine Needle Aspiration (FNA): Fine needle aspiration is a type of biopsy procedure. In fine needle aspiration, a thin needle is inserted into an area of abnormal-appearing tissue or body fluid, and histological material is obtained. FNA will be performed with a standard 25g needle in the usual fashion using back and forth passes for 30 seconds. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total DNA Yield of Adenocarcinoma | Total quantity of DNA obtained from first needle pass of adenocarcinoma, measured in ng/µL. | Posted | Mean | Standard Deviation | ng/µL | Baseline |
|
Adverse events were assessed immediately after the procedure and during the first 30 days with a follow-up telephone call or clinical visit for each subject, for a total of approximately two and a half years.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fine Needle Biopsy (FNB) | Fine Needle Biopsy (FNB): The Shark Core FNB is an FDA approved device for sampling of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses. FNB will be performed by 22 gauge for pancreas head and by 19 gauge for all the other sites. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatitis | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael B. Wallace | Mayo Clinic | 904-953-2222 | wallace.michael@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 9, 2017 | Nov 15, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D044963 | Biopsy, Fine-Needle |
| ID | Term |
|---|---|
| D001707 | Biopsy, Needle |
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
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|
| Fine Needle Aspiration (FNA) | Device | Fine needle aspiration is a type of biopsy procedure. In fine needle aspiration, a thin needle is inserted into an area of abnormal-appearing tissue or body fluid, and histological material is obtained. FNA will be performed with a standard 25g needle in the usual fashion using back and forth passes for 30 seconds. |
|
The length of the tissue core sample acquired, on the first needle pass, measured in centimeters.
| Baseline |
| Concentration of DNA Yield of Adenocarcinoma | The concentration of the DNA from the adenocarcinoma on the first needle pass, measured in micrograms per microliter. | Baseline |
| Percentage of Tumor Cellularity | Percent of tumor cellularity with first pass of adenocarcinoma | Baseline |
| Total Number of Subjects Where First-pass Biopsy Contained Adequate Material for Cytologic Interpretation | The total number of subjects whose first-pass biopsy contained adequate material for cytologic interpretation, as determined by a cytopathologist. | Baseline |
| Total Number of Subjects Where First-pass Biopsy Contained Adequate Material for High Quality Histologic Interpretation | The number of subjects whose first pass biopsy contained adequate material for high quality histologic interpretation, as determined by a cytopathologist. High quality is defined as being greater than 10 power field in length. | Baseline |
| NOT COMPLETED |
|
| BG001 | FNA First, Then FNB | In an endoscopic ultrasound-guided procedure, Fine Needle Aspiration (FNA) will be performed first, followed by Shark Core Fine Needle Biopsy (FNB). Fine Needle Biopsy (FNB): The Shark Core FNB is an FDA approved device for sampling of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses. FNB will be performed by 22 gauge for pancreas head and by 19 gauge for all the other sites. Fine Needle Aspiration (FNA): Fine needle aspiration is a type of biopsy procedure. In fine needle aspiration, a thin needle is inserted into an area of abnormal-appearing tissue or body fluid, and histological material is obtained. FNA will be performed with a standard 25g needle in the usual fashion using back and forth passes for 30 seconds. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Total Number of Passes Needed to Obtain Adequate Tissue Sample for Cytology/Histology Diagnosis | The total number of passes required to obtain adequate tissue sample for cytology/histology processing and interpretation. | Posted | Median | Full Range | needle passes | Baseline |
|
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| Secondary | Core Tissue Length | The length of the tissue core sample acquired, on the first needle pass, measured in centimeters. | Posted | Median | Full Range | centimeters | Baseline |
|
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| Secondary | Concentration of DNA Yield of Adenocarcinoma | The concentration of the DNA from the adenocarcinoma on the first needle pass, measured in micrograms per microliter. | Posted | Mean | Standard Deviation | µg/mL | Baseline |
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| Secondary | Percentage of Tumor Cellularity | Percent of tumor cellularity with first pass of adenocarcinoma | Posted | Median | Full Range | percentage of tumor cellularity | Baseline |
|
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|
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| Secondary | Total Number of Subjects Where First-pass Biopsy Contained Adequate Material for Cytologic Interpretation | The total number of subjects whose first-pass biopsy contained adequate material for cytologic interpretation, as determined by a cytopathologist. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Total Number of Subjects Where First-pass Biopsy Contained Adequate Material for High Quality Histologic Interpretation | The number of subjects whose first pass biopsy contained adequate material for high quality histologic interpretation, as determined by a cytopathologist. High quality is defined as being greater than 10 power field in length. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 2 |
| 50 |
| EG001 | Fine Needle Aspiration (FNA) | Fine Needle Aspiration (FNA): Fine needle aspiration is a type of biopsy procedure. In fine needle aspiration, a thin needle is inserted into an area of abnormal-appearing tissue or body fluid, and histological material is obtained. FNA will be performed with a standard 25g needle in the usual fashion using back and forth passes for 30 seconds. | 0 | 50 | 0 | 50 | 0 | 50 |
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D019411 |
| Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D011677 | Punctures |
| D008919 | Investigative Techniques |