SECRETIN SYNTHETIC HUMAN for Pancreatic cancer | Intraductal papillary mucinous neoplasm

Inclusion criteria

• {"criterion_text":"- 1. Be a man or woman over 18 years of age.\n- 2. Willing to comply with the study procedures described in the protocol.\n- 3. Willing and able to give written informed consent.\n- 4. Meeting at least one of the following three criteria related to the diagnosis or prognosis of IPMN: 4.1. Diagnosis of IPMN based on evidence of the major criterion or the presence of at least 2 minor criteria. -Major criterion: Characteristic imaging on MRI and/or EUS (single or multiple cysts with clear ductal communication and/or focal or diffuse dilation ≥ 5 mm in diameter of the main pancreatic duct without apparent obstructive cause). -Minor criteria: a) Mucus-secreting cells and/or extracellular mucin in the cytological examination of intracystic fluid. b) Clearly mucoid or filamentous appearance of the intracystic fluid. c) CEA concentration in intracystic fluid >192 ng/mL or intracystic glucose < 50 mg/dL.\n- 4.2. IPMN with cysts with a diameter ≥ 10 mm and/or focal or diffuse dilatation of the main pancreatic duct with a diameter ≥ 7 mm requiring EUS-FNA for diagnostic purposes or to assess risk or existence of malignancy following the main clinical practice guidelines.\n- 4.3. IPMN with indication for surgical resection of the lesion.\n- 5. If the participant is a woman of childbearing potential, she must be willing to use highly effective contraceptive methods or practice sexual abstinence from the screening visit until one week after undergoing the procedure under study. Highly effective contraceptive methods include: combined (containing estrogen and progestogen) oral, intravaginal, or transdermal hormonal contraception associated with ovulation inhibition; progestogen-only oral, injectable, or implantable hormonal contraception associated with ovulation inhibition; intrauterine device; intrauterine hormone-releasing system; bilateral tubal occlusion; vasectomized partner; and sexual abstinence.\n- 6. If the participant is a woman of reproductive age, she must be willing to undergo a urine pregnancy test prior to inclusion in the study."}

Exclusion criteria

• {"criterion_text":"- History of surgery that prevents endoscopic access to the ampulla of Vater in the case of AJPD-sec, or to the area of the stomach or intestine from which to perform FNA.\n- Acute pancreatitis within the 30 days prior to inclusion.\n- Pregnant women, women with the possibility of pregnancy during the month prior to inclusion, or women who are breastfeeding.\n- Coagulopathy (PT < 25%, INR > 1.5, platelets < 50,000/mL) preventing FNA.\n- Renal failure with GFR < 30 mL/min or patients on dialysis.\n- Known hypersensitivity to any component of the ChiRhoStim® (human secretin) formulation.\n- Any clinically relevant medical condition that, in the opinion of the investigator, makes the patient unfit to participate in the study (underlying haematological disorders, autoimmune disease, immunodeficiency, gastrointestinal, psychiatric, renal, hepatic and cardiopulmonary disorders)."}

Primary endpoints

• {"endpoint_text":"- Proportion of patients with IPMN with GNAS and KRAS mutations in intracystic fluid obtained by EUS-FNA versus pancreatic juice obtained by ADPJ-secr after both techniques.","definition_or_measurement_approach":"Detection of somatic mutations in GNAS and KRAS in liquid samples obtained by the two techniques (intracystic fluid from EUS-FNA and pancreatic juice from ADPJ-secr) as specified in the primary objective."}

Secondary endpoints

• {"endpoint_text":"- 1. Proportion of patients with IPMN with Tp53 mutations in samples obtained by EUS-FNA versus AJPD-sec after performing both techniques, in the subgroup of patients undergoing pancreatic resection within 12 months after inclusion in the study.","definition_or_measurement_approach":""}
• {"endpoint_text":"- 2. DNA concentration expressed in ng/μl in samples obtained by EUSFNA versus ADPJ-secr after performing both techniques.","definition_or_measurement_approach":"DNA concentration measured and expressed in ng/μl."}
• {"endpoint_text":"- 3. Proportion of suitable samples obtained by the two techniques under study (ADPJ-secr and EUS-FNA) for molecular analysis. * A sample is defined as suitable when it is read by the Qubit fluorometer, which only detects full double-stranded DNA suitable for molecular analysis.","definition_or_measurement_approach":"A sample is defined as suitable when it is read by the Qubit fluorometer, which only detects full double-stranded DNA suitable for molecular analysis."}
• {"endpoint_text":"- 4. Proportion of patients undergoing pancreatic resection with a pathological diagnosis of IPMN who have mutations in GNAS and/or KRAS in samples obtained by EUS-FNA versus ADPJ-secr within 12 months of study entry.","definition_or_measurement_approach":""}
• {"endpoint_text":"- 5. Proportion of patients undergoing pancreatic resection without a pathological diagnosis of IPMN who do not have GNAS and/or KRAS mutations in samples obtained by EUS-FNA versus ADPJ-secr within 12 months of study entry.","definition_or_measurement_approach":""}
• {"endpoint_text":"- 6. Proportion of patients undergoing pancreatic resection with Tp53 mutations in samples obtained by both techniques under study (ADPJsecr vs EUS-FNA) who have advanced neoplasia in the surgical resection specimen after surgery performed within 12 months after study inclusion.","definition_or_measurement_approach":""}
• {"endpoint_text":"- 7. Proportion of patients undergoing pancreatic resection without Tp53 mutations in samples obtained by both techniques under study (ADPJsecr vs EUS-FNA) who do not have advanced neoplasia in the surgical resection specimen after surgery performed within 12 months after inclusion in the study.","definition_or_measurement_approach":""}
• {"endpoint_text":"- 8.1. To evaluate the association between mutational status (GNAS/KRAS mutated versus GNAS/KRAS non-mutated [wild type]) in samples obtained by both techniques under study (EUS-FNA vs AJPD-sec) in relation to the following clinical-analytical variables: age, sex, toxic habits (smoking, chronic alcohol consumption)","definition_or_measurement_approach":""}
• {"endpoint_text":"- 8.2. Comorbidities, history of acute pancreatitis, previous diagnosis of chronic pancreatitis, first-degree family history of pancreatic cancer, duration since IPMN diagnosis, morphological type of IPMN (IPMN-MC, IPMN-MP, mixed IPMN), blood levels of amylase, lipase, creatinine, total bilirubin, AST/ALT, GGT/ALP, creatinine, hemoglobin, platelets, CA 19-9, CEA, and glycated hemoglobin.","definition_or_measurement_approach":""}
• {"endpoint_text":"- 9. To evaluate the association between mutational status in samples obtained by both techniques under study in relation to the following morphological characteristics of the lesion obtained by EUS: diameter of the largest cystic lesion, maximum diameter of the main pancreatic duct, type of pancreatic duct dilation, lesion location, presence of cystic lesion, mural nodules, signs of chronic pancreatitis, intraductal calcifications, pancreatic atrophy, and final EUS diagnosis of the lesion.","definition_or_measurement_approach":""}
• {"endpoint_text":"- 10. To evaluate the association between mutational status in samples obtained by both techniques under study in relation to the following technical characteristics of EUS-FNA and AJPD-sec: access route for FNA, punctured lesion, location of the punctured lesion, needle gauge used, type of needle used, number of passes, amount of fluid obtained by both techniques, type of endoscope used for AJPD-sec.","definition_or_measurement_approach":""}
• {"endpoint_text":"- 11. To evaluate the association between mutational status (GNAS/KRAS mutated versus GNAS/KRAS non-mutated [wild type]) in samples obtained by both techniques under study (EUS-FNA vs AJPD-sec) in relation to the following morphological characteristics of the intracystic fluid: filamentous or non-filamentous.","definition_or_measurement_approach":""}
• {"endpoint_text":"- 12. To evaluate the association between mutational status (GNAS/KRAS mutated versus GNAS/KRAS non-mutated [wild type]) in samples obtained by both techniques under study (EUS-FNA vs AJPD-sec) in relation to the following biochemical characteristics: CEA, glucose, and amylase.","definition_or_measurement_approach":""}
• {"endpoint_text":"- 13. To evaluate the association between mutational status (GNAS/KRAS mutated versus GNAS/KRAS non-mutated [wild type]) in samples obtained by both techniques under study (EUS-FNA vs AJPD-sec) in relation to the following cytological characteristics of the intracystic fluid: mucus-secreting cells, mucin, and final cytological diagnosis.","definition_or_measurement_approach":""}
• {"endpoint_text":"- 14. Proportion of patients in whom AJPD-sec could be performed with a gastroscope with a cap without the need for rescue with a duodenoscope.","definition_or_measurement_approach":""}
• {"endpoint_text":"- 15. Evaluate whether any of the variables assessed in objectives 8, 9, 10, 11, 12, or 13 predict the inability to obtain a pancreatic juice sample using a cap-fitted gastroscope after performing both techniques under study.","definition_or_measurement_approach":""}
• {"endpoint_text":"- 16. Proportion of patients with adverse effects related to the techniques under study (EUS-FNA and AJPD-secr) defined according to the criteria of the American Society of Gastrointestinal Endoscopy (PB Cotton, et al. Gastrointest Endosc, 2010) at 24 hours and 7 days after the procedures.","definition_or_measurement_approach":"Adverse effects defined according to American Society of Gastrointestinal Endoscopy (PB Cotton et al., Gastrointest Endosc, 2010); assessed at 24 hours and 7 days."}
• {"endpoint_text":"- 17. Evaluate whether any of the variables assessed in objectives 8, 9, 10, 11, 12, or 13 predict the occurrence of adverse effects associated with the techniques under study at 24 hours and 7 days after the procedures.","definition_or_measurement_approach":""}
• {"endpoint_text":"- 18. Proportion of patients with Serious Adverse Events at 24 hours and 7 days after the procedures under study.","definition_or_measurement_approach":""}

Spain

Earliest CTIS Part Ii Submission Date

13-12-2024

Latest Decision Or Authorization Date

14-01-2025

Processing Time Days

32

Number Of Sites

3

Number Of Participants

140

Primary sponsor

Full Name

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain