Pancreatic CystCYST-GENNCT03305146
Feasibility of Molecular Biology in Pancreatic Cyst Tumors
A study testing Molecular biology analysis of pancreatic intra-cyst fluid in people with Pancreatic Cyst and Pancreas Cyst, run by Hospital St. Joseph, Marseille, France at 11 sites in France.
Trial summary
The main objective of the study is to compare the diagnostic accuracy of intra-cystic fluid DNA molecular analysis to standard diagnostics. The secondary objective of the study is to evaluate the feasibility of intra-cystic fluid DNA molecular analysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cyst, Pancreas Cyst, Serous Cystadenoma
- What is being tested?
- Molecular biology analysis of pancreatic intra-cyst fluid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 11 sitesFrance
- Study dates
- Jan 2017to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient older than 18 years of age, male or female
- Cystic tumor of the pancreas requiring a puncture under endoscopic control to determine the etiologic diagnosis and gravity.
Who cannot join
- Doubts regarding the etiological diagnosis of the pancreatic cyst
- Contraindications for the realization of a high digestive endoscopy
- Haemorrhagic disorder, haemostasis and coagulation disorder (TP <60%, TCa> 40 sec and platelets <60000 / mm3).
- AVK, AOD and AAP cannot be stopped
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Clinique de Bercy
Charenton-le-Pont, 94220
Centre Hospitalier Universitaire Dupuytren
Limoges, 87000
Hopital Edouard Herriot
Lyon, 69003
Hopital Mermoz
Lyon, 69008
Hopital Europeen
Marseille, 13003
Hopital Saint Joseph
Marseille, 13008
Chu La Timone
Marseille, 13385
CHU NANTES Institut des Maladies de l'Appareil Digestif
Nantes, 44000
Chu L'Archet 2
Nice, 06200
Hopital Saint Joseph
Paris, 75014
Centre Hospitalier Jacques Lacarin
Vichy, 03207
About this study
Official title: Study of Feasibility and Diagnostic Profitability of Intra-cyst Fluid Molecular Biology Analysis in Pancreatic Cyst Tumors.
The main objective of the study is to compare the diagnostic accuracy of intra-cystic fluid DNA molecular analysis to standard diagnostics.
The secondary objective of the study is to evaluate the feasibility of intra-cystic fluid DNA molecular analysis.
Read the detailed description
Multicenter study to determinate the feasibility of intra-cystic fluid DNA molecular analysis in patients with suspected cystic tumours of pancreas in whom EUS FNA is clinically indicated.
Morphological criteria obtained by MRI and computerised tomography (tumor characterization (size, metastases presence, dilatation of bile ducts), etiologic diagnosis, serious symptoms), biological exams (biomarkers), cytological analysis will lead to a diagnosis and a treatment.
The goal of this study is to compare this standard diagnostic modalities to diagnosis obtained by intra-cystic fluid DNA molecular analysis.
Is the DNA molecular analysis improve the diagnosis accuracy.
- Conditions
- Pancreatic Cyst, Pancreas Cyst, Serous Cystadenoma, Mucinous Cystadenoma, IPMN
- Being tested
- Molecular biology analysis of pancreatic intra-cyst fluid
- Medical subject headings
- Pancreatic Cyst, Cystadenoma, Serous, Cystadenoma, Mucinous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molecular biology analysis of pancreatic intra-cyst fluidGenetic
The EUS FNA will be performed according to the Francophone Club of Echo Endoscopy recommendations.
For molecular biology technique, the samples will be processed within the UMR_S910 unit. Nucleic acids will be extracted from the intra-cystic fluid or, for post-operative patients, from a resected specimen that will be collected into a tube containing a nucleic acid stabilization solution (Allprotect Tissue reagent, Qiagen).
The nucleic acids will be extracted and then sequenced. The sequencing technology chosen (HaloPlexHS, Agilent) allows a detection close to 1% in allelic frequency. This new technical approach that links high sensitivity and specificity is also suitable with degraded and/or low-volume ( <50ng) DNA.
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | For inoperable patients with indeterminate cystic lesions of the pancreas,a EUS FNA will be performed and molecular biology analysis of pancreatic intra-cyst fluid collected by EUS FNA will be performed.
For operable patients, after the pancreatic surgery, molecular biology analysis of extemporaneous pancreatic tissue specimen biopsy will be conducted. Receives: Genetic: Molecular biology analysis of pancreatic intra-cyst fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between gene mutations found into the pancreatic cystic tumor fluid to gene mutations found into tissue specimen
The nucleic acids of the samples will be extracted and then sequenced on a panel of about 70 genes implicated in the pancreatic tumorigenesis and targeting RAS, MAPK, AKT, JAK-STAT, WNT, TGFB, TP53 and Repair BRCA, ATM. The selected sequencing technology (HaloPlexHS ®, Agilent) will be used. A comparison of the molecular profiles between the cystic fluid and the surgical specimen will be carried out and then confronted with the pathology, biological, radiological and clinical characterization
Measured: 10 days
Secondary outcomes (1)
Evaluate the feasibility of the molecular biology analysis of the pancreatic cystic tumor fluid to distinguish the pancreatic cysts.
The nucleic acids of the samples will be extracted from the different cyst fluids and then sequenced. A comparison of the molecular profiles between the different cystic fluids will be carried out and then confronted with the pathology, biological, radiological and clinical characterization
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2017
- Study startJan 2017
- Primary completionDec 2017
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CystStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- First 20 patients for pilot study to test the feasibility of the molecular analysis then 120 patients to continue the trial.
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital St. Joseph, Marseille, France
- Sponsor type
- University, hospital or other
- Collaborators
- GCS Ramsay Santé pour l'Enseignement et la Recherche
- Responsible party
- Principal investigator, Arthur Laquiere, Hospital St. Joseph, Marseille, France
- Investigators
- Arthur Laquière, MD, Principal investigator, French Society of Digestive Endoscopy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03305146
- Sponsor's protocol ID
- 2016-A01399-42
- Acronym
- CYST-GEN
- Status last verified
- Apr 2022
- First submitted
- 14 Jun 2017
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee KS, Sekhar A, Rofsky NM, Pedrosa I. Prevalence of incidental pancreatic cysts in the adult population on MR imaging. Am J Gastroenterol. 2010 Sep;105(9):2079-84. doi: 10.1038/ajg.2010.122. Epub 2010 Mar 30.
PubMed 20354507Farrell JJ, Fernandez-del Castillo C. Pancreatic cystic neoplasms: management and unanswered questions. Gastroenterology. 2013 Jun;144(6):1303-15. doi: 10.1053/j.gastro.2013.01.073.
PubMed 23622140Terris B, Ponsot P, Paye F, Hammel P, Sauvanet A, Molas G, Bernades P, Belghiti J, Ruszniewski P, Flejou JF. Intraductal papillary mucinous tumors of the pancreas confined to secondary ducts show less aggressive pathologic features as compared with those involving the main pancreatic duct. Am J Surg Pathol. 2000 Oct;24(10):1372-7. doi: 10.1097/00000478-200010000-00006.
PubMed 11023098Crippa S, Fernandez-Del Castillo C, Salvia R, Finkelstein D, Bassi C, Dominguez I, Muzikansky A, Thayer SP, Falconi M, Mino-Kenudson M, Capelli P, Lauwers GY, Partelli S, Pederzoli P, Warshaw AL. Mucin-producing neoplasms of the pancreas: an analysis of distinguishing clinical and epidemiologic characteristics. Clin Gastroenterol Hepatol. 2010 Feb;8(2):213-9. doi: 10.1016/j.cgh.2009.10.001. Epub 2009 Oct 14.
PubMed 19835989Marchegiani G, Mino-Kenudson M, Sahora K, Morales-Oyarvide V, Thayer S, Ferrone C, Warshaw AL, Lillemoe KD, Fernandez-Del Castillo C. IPMN involving the main pancreatic duct: biology, epidemiology, and long-term outcomes following resection. Ann Surg. 2015 May;261(5):976-83. doi: 10.1097/SLA.0000000000000813.
PubMed 24979607Tanaka M, Fernandez-del Castillo C, Adsay V, Chari S, Falconi M, Jang JY, Kimura W, Levy P, Pitman MB, Schmidt CM, Shimizu M, Wolfgang CL, Yamaguchi K, Yamao K; International Association of Pancreatology. International consensus guidelines 2012 for the management of IPMN and MCN of the pancreas. Pancreatology. 2012 May-Jun;12(3):183-97. doi: 10.1016/j.pan.2012.04.004. Epub 2012 Apr 16.
PubMed 22687371Brugge WR, Lewandrowski K, Lee-Lewandrowski E, Centeno BA, Szydlo T, Regan S, del Castillo CF, Warshaw AL. Diagnosis of pancreatic cystic neoplasms: a report of the cooperative pancreatic cyst study. Gastroenterology. 2004 May;126(5):1330-6. doi: 10.1053/j.gastro.2004.02.013.
PubMed 15131794Serikawa M, Sasaki T, Fujimoto Y, Kuwahara K, Chayama K. Management of intraductal papillary-mucinous neoplasm of the pancreas: treatment strategy based on morphologic classification. J Clin Gastroenterol. 2006 Oct;40(9):856-62. doi: 10.1097/01.mcg.0000225609.63975.6f.
PubMed 17016145Bournet B, Kirzin S, Carrere N, Portier G, Otal P, Selves J, Musso C, Suc B, Moreau J, Fourtanier G, Pradere B, Lazorthes F, Escourrou J, Buscail L. Clinical fate of branch duct and mixed forms of intraductal papillary mucinous neoplasia of the pancreas. J Gastroenterol Hepatol. 2009 Jul;24(7):1211-7. doi: 10.1111/j.1440-1746.2009.05826.x. Epub 2009 May 19.
PubMed 19476563Sugiyama M, Izumisato Y, Abe N, Masaki T, Mori T, Atomi Y. Predictive factors for malignancy in intraductal papillary-mucinous tumours of the pancreas. Br J Surg. 2003 Oct;90(10):1244-9. doi: 10.1002/bjs.4265.
PubMed 14515294Kanno A, Satoh K, Hirota M, Hamada S, Umino J, Itoh H, Masamune A, Asakura T, Shimosegawa T. Prediction of invasive carcinoma in branch type intraductal papillary mucinous neoplasms of the pancreas. J Gastroenterol. 2010 Sep;45(9):952-9. doi: 10.1007/s00535-010-0238-0. Epub 2010 Apr 10.
PubMed 20383536Crippa S, Salvia R, Warshaw AL, Dominguez I, Bassi C, Falconi M, Thayer SP, Zamboni G, Lauwers GY, Mino-Kenudson M, Capelli P, Pederzoli P, Castillo CF. Mucinous cystic neoplasm of the pancreas is not an aggressive entity: lessons from 163 resected patients. Ann Surg. 2008 Apr;247(4):571-9. doi: 10.1097/SLA.0b013e31811f4449.
PubMed 18362619Cizginer S, Turner BG, Bilge AR, Karaca C, Pitman MB, Brugge WR. Cyst fluid carcinoembryonic antigen is an accurate diagnostic marker of pancreatic mucinous cysts. Pancreas. 2011 Oct;40(7):1024-8. doi: 10.1097/MPA.0b013e31821bd62f.
PubMed 21775920Sahora K, Mino-Kenudson M, Brugge W, Thayer SP, Ferrone CR, Sahani D, Pitman MB, Warshaw AL, Lillemoe KD, Fernandez-del Castillo CF. Branch duct intraductal papillary mucinous neoplasms: does cyst size change the tip of the scale? A critical analysis of the revised international consensus guidelines in a large single-institutional series. Ann Surg. 2013 Sep;258(3):466-75. doi: 10.1097/SLA.0b013e3182a18f48.
PubMed 24022439Wu BU, Sampath K, Berberian CE, Kwok KK, Lim BS, Kao KT, Giap AQ, Kosco AE, Akmal YM, Difronzo AL, Yu W, Ngor EW. Prediction of malignancy in cystic neoplasms of the pancreas: a population-based cohort study. Am J Gastroenterol. 2014 Jan;109(1):121-9; quiz 130. doi: 10.1038/ajg.2013.334. Epub 2013 Oct 1.
PubMed 24080609
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Feasibility and Diagnostic Profitability of Intra-cyst Fluid Molecular Biology Analysis in Pancreatic Cyst Tumors.
- ClinicalTrials.gov ID
- NCT03305146
- Acronym / sponsor ID
- CYST-GEN / 2016-A01399-42
- Conditions
- Pancreatic Cyst, Pancreas Cyst, Serous Cystadenoma, Mucinous Cystadenoma, IPMN
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Hospital St. Joseph, Marseille, FranceUniversity, hospital or other
- Collaborators
- GCS Ramsay Santé pour l'Enseignement et la Recherche
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jan 2027 (estimated)
- First posted
- 9 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of the study is to compare the diagnostic accuracy of intra-cystic fluid DNA molecular analysis to standard diagnostics.
The secondary objective of the study is to evaluate the feasibility of intra-cystic fluid DNA molecular analysis.
Detailed description
Multicenter study to determinate the feasibility of intra-cystic fluid DNA molecular analysis in patients with suspected cystic tumours of pancreas in whom EUS FNA is clinically indicated.
Morphological criteria obtained by MRI and computerised tomography (tumor characterization (size, metastases presence, dilatation of bile ducts), etiologic diagnosis, serious symptoms), biological exams (biomarkers), cytological analysis will lead to a diagnosis and a treatment.
The goal of this study is to compare this standard diagnostic modalities to diagnosis obtained by intra-cystic fluid DNA molecular analysis.
Is the DNA molecular analysis improve the diagnosis accuracy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- First 20 patients for pilot study to test the feasibility of the molecular analysis then 120 patients to continue the trial.
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Genetic: Molecular biology analysis of pancreatic intra-cyst fluidFor inoperable patients with indeterminate cystic lesions of the pancreas,a EUS FNA will be performed and molecular biology analysis of pancreatic intra-cyst fluid collected by EUS FNA will be performed. For operable patients, after the pancreatic surgery, molecular biology analysis of extemporaneous pancreatic tissue specimen biopsy will be conducted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient older than 18 years of age, male or female
- Cystic tumor of the pancreas requiring a puncture under endoscopic control to determine the etiologic diagnosis and gravity.
Key exclusion criteria (4 listed)
- Doubts regarding the etiological diagnosis of the pancreatic cyst
- Contraindications for the realization of a high digestive endoscopy
- Haemorrhagic disorder, haemostasis and coagulation disorder (TP <60%, TCa> 40 sec and platelets <60000 / mm3).
- AVK, AOD and AAP cannot be stopped
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Molecular biology analysis of pancreatic intra-cyst fluidThe EUS FNA will be performed according to the Francophone Club of Echo Endoscopy recommendations. For molecular biology technique, the samples will be processed within the UMR_S910 unit. Nucleic acids will be extracted from the intra-cystic fluid or, for post-operative patients, from a resected specimen that will be collected into a tube containing a nucleic acid stabilization solution (Allprotect Tissue reagent, Qiagen). The nucleic acids will be extracted and then sequenced. The sequencing technology chosen (HaloPlexHS, Agilent) allows a detection close to 1% in allelic frequency. This new technical approach that links high sensitivity and specificity is also suitable with degraded and/or low-volume ( <50ng) DNA. | Genetic | single arm |
Primary outcome
Comparison between gene mutations found into the pancreatic cystic tumor fluid to gene mutations found into tissue specimen
Time frame: 10 days
The nucleic acids of the samples will be extracted and then sequenced on a panel of about 70 genes implicated in the pancreatic tumorigenesis and targeting RAS, MAPK, AKT, JAK-STAT, WNT, TGFB, TP53 and Repair BRCA, ATM. The selected sequencing technology (HaloPlexHS ®, Agilent) will be used. A comparison of the molecular profiles between the cystic fluid and the surgical specimen will be carried out and then confronted with the pathology, biological, radiological and clinical characterization
1 secondary outcome
Evaluate the feasibility of the molecular biology analysis of the pancreatic cystic tumor fluid to distinguish the pancreatic cysts.
Time frame: up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Background: PubMed 20354507Lee KS, Sekhar A, Rofsky NM, Pedrosa I. Prevalence of incidental pancreatic cysts in the adult population on MR imaging. Am J Gastroenterol. 2010 Sep;105(9):2079-84. doi: 10.1038/ajg.2010.122. Epub 2010 Mar 30.
- Background: PubMed 23622140Farrell JJ, Fernandez-del Castillo C. Pancreatic cystic neoplasms: management and unanswered questions. Gastroenterology. 2013 Jun;144(6):1303-15. doi: 10.1053/j.gastro.2013.01.073.
- Background: PubMed 11023098Terris B, Ponsot P, Paye F, Hammel P, Sauvanet A, Molas G, Bernades P, Belghiti J, Ruszniewski P, Flejou JF. Intraductal papillary mucinous tumors of the pancreas confined to secondary ducts show less aggressive pathologic features as compared with those involving the main pancreatic duct. Am J Surg Pathol. 2000 Oct;24(10):1372-7. doi: 10.1097/00000478-200010000-00006.
- Background: PubMed 19835989Crippa S, Fernandez-Del Castillo C, Salvia R, Finkelstein D, Bassi C, Dominguez I, Muzikansky A, Thayer SP, Falconi M, Mino-Kenudson M, Capelli P, Lauwers GY, Partelli S, Pederzoli P, Warshaw AL. Mucin-producing neoplasms of the pancreas: an analysis of distinguishing clinical and epidemiologic characteristics. Clin Gastroenterol Hepatol. 2010 Feb;8(2):213-9. doi: 10.1016/j.cgh.2009.10.001. Epub 2009 Oct 14.
- Background: PubMed 24979607Marchegiani G, Mino-Kenudson M, Sahora K, Morales-Oyarvide V, Thayer S, Ferrone C, Warshaw AL, Lillemoe KD, Fernandez-Del Castillo C. IPMN involving the main pancreatic duct: biology, epidemiology, and long-term outcomes following resection. Ann Surg. 2015 May;261(5):976-83. doi: 10.1097/SLA.0000000000000813.
- Background: PubMed 22687371Tanaka M, Fernandez-del Castillo C, Adsay V, Chari S, Falconi M, Jang JY, Kimura W, Levy P, Pitman MB, Schmidt CM, Shimizu M, Wolfgang CL, Yamaguchi K, Yamao K; International Association of Pancreatology. International consensus guidelines 2012 for the management of IPMN and MCN of the pancreas. Pancreatology. 2012 May-Jun;12(3):183-97. doi: 10.1016/j.pan.2012.04.004. Epub 2012 Apr 16.
- Background: PubMed 15131794Brugge WR, Lewandrowski K, Lee-Lewandrowski E, Centeno BA, Szydlo T, Regan S, del Castillo CF, Warshaw AL. Diagnosis of pancreatic cystic neoplasms: a report of the cooperative pancreatic cyst study. Gastroenterology. 2004 May;126(5):1330-6. doi: 10.1053/j.gastro.2004.02.013.
- Background: PubMed 17016145Serikawa M, Sasaki T, Fujimoto Y, Kuwahara K, Chayama K. Management of intraductal papillary-mucinous neoplasm of the pancreas: treatment strategy based on morphologic classification. J Clin Gastroenterol. 2006 Oct;40(9):856-62. doi: 10.1097/01.mcg.0000225609.63975.6f.
- Background: PubMed 19476563Bournet B, Kirzin S, Carrere N, Portier G, Otal P, Selves J, Musso C, Suc B, Moreau J, Fourtanier G, Pradere B, Lazorthes F, Escourrou J, Buscail L. Clinical fate of branch duct and mixed forms of intraductal papillary mucinous neoplasia of the pancreas. J Gastroenterol Hepatol. 2009 Jul;24(7):1211-7. doi: 10.1111/j.1440-1746.2009.05826.x. Epub 2009 May 19.
- Background: PubMed 14515294Sugiyama M, Izumisato Y, Abe N, Masaki T, Mori T, Atomi Y. Predictive factors for malignancy in intraductal papillary-mucinous tumours of the pancreas. Br J Surg. 2003 Oct;90(10):1244-9. doi: 10.1002/bjs.4265.
- Background: PubMed 20383536Kanno A, Satoh K, Hirota M, Hamada S, Umino J, Itoh H, Masamune A, Asakura T, Shimosegawa T. Prediction of invasive carcinoma in branch type intraductal papillary mucinous neoplasms of the pancreas. J Gastroenterol. 2010 Sep;45(9):952-9. doi: 10.1007/s00535-010-0238-0. Epub 2010 Apr 10.
- Background: PubMed 18362619Crippa S, Salvia R, Warshaw AL, Dominguez I, Bassi C, Falconi M, Thayer SP, Zamboni G, Lauwers GY, Mino-Kenudson M, Capelli P, Pederzoli P, Castillo CF. Mucinous cystic neoplasm of the pancreas is not an aggressive entity: lessons from 163 resected patients. Ann Surg. 2008 Apr;247(4):571-9. doi: 10.1097/SLA.0b013e31811f4449.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arthur Laquière, MD principal investigator
French Society of Digestive Endoscopy
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Molecular biology analysis of pancreatic intra-cyst fluid in people with Pancreatic Cyst and Pancreas Cyst, run by Hospital St. Joseph, Marseille, France at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between gene mutations found into the pancreatic cystic tumor fluid to gene mutations found into tissue specimen (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03305146, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.