Lynch SyndromeEndoLynchNCT02951390
High Definition White-Light Colonoscopy vs. Chromoendoscopy for Surveillance of Lynch Syndrome.
A study testing High-definition white-light endoscopy in people with Lynch Syndrome, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
Adenomas in Lynch syndrome have an accelerated progression to colorectal cancer (CRC) which might occur despite a regular follow-up. Despite low evidence, high-definition technology (HD) and indigo-carmine chromoendoscopy (CE) are recommended for surveillance in Lynch syndrome.The investigators will conduct a… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lynch Syndrome
- What is being tested?
- High-definition white-light endoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2016to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with proven pathologic germline mutation in one of the mismatch-repair (MMR) gene (MLH1, MSH2, MSH6, PMS2 or Epcam) who will undergo surveillance colonoscopy
Who cannot join
- Patients with total colectomy
- Concomitant inflammatory bowel disease
- Inadequate bowel preparation (Boston scale <2 in any colonic segment)
- Incomplete procedure (without intubation of cecum or ileo-colonic anastomosis)
- Previous colonoscopy in less than one year
- Inability to sign informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Definition White-Light Colonoscopy Versus Chromoendoscopy for Surveillance of Lynch Syndrome. A Prospective, Multicenter and Randomized Study
Adenomas in Lynch syndrome have an accelerated progression to colorectal cancer (CRC) which might occur despite a regular follow-up. Despite low evidence, high-definition technology (HD) and indigo-carmine chromoendoscopy (CE) are recommended for surveillance in Lynch syndrome.The investigators will conduct a prospective multicenter randomized non-inferiority study. The principal aim is to compare the adenoma detection rate with WLE vs CE. Our hypothesis is that HD-white-light endoscopy (WLE) is not inferior to CE. Therefore - under expert hands - HD-CE does not add any significant advantage over HD-WLE on adenoma detection rate in patients with Lynch syndrome.
Read the detailed description
The investigators will conduct a prospective multicenter randomized non-inferiority study. Eligible patients will be those with Lynch syndrome (known germline mutation in mismatch repair genes) who undergo surveillance colonoscopies. Patients will be sequentially assigned in a 1:1 ratio to HD-WLE or HD-CE. The method of stratified randomization based on partial colectomy history will be used to avoid proportion imbalance between groups. Participant centers must have an organized high-risk of CRC clinic and endoscopic unit provided with HD technology. Endoscopists must have a documented high adenoma detection rate and experience in performing CE in patients with high-risk conditions of CRC.
The principal aim is to compare the adenoma detection rate with WLE vs CE. Principal outcome measures will be: 1) adenoma detection rate, defined as the proportion of patients with at least one adenoma in each arm; 2) number of adenomas per patient, defined as the total number of detected adenomas in each arm (HD-WLE or HD-CE) divided by the number of colonoscopies in each arm.
The sample size calculation was determined for a non-inferiority study. Assuming an ADR of 28% with conventional chromoendoscopy in patients with Lynch syndrome, a 15% non-inferiority margin, a one-sided significance level of 0.05 powered at 80% and a 10% of drop-off. Based on these assumptions, it was determined that 122 patients were required for each arm (a total of 244).
- Conditions
- Lynch Syndrome
- Being tested
- High-definition white-light endoscopy
- Keywords
- Surveillance, Colorectal cancer, Colonoscopy, Adenoma, Chromoendoscopy
- Medical subject headings
- Colorectal Neoplasms, Hereditary Nonpolyposis, Colorectal Neoplasms, Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-definition white-light endoscopyOther
The intervention is do not perform chromoendoscopy
| Study group | Role | What they receive |
|---|---|---|
| High-definition white-light endoscopy | Active comparator | High-definition white-light endoscopy without indigo carmine instilation Receives: Other: High-definition white-light endoscopy |
| High-definition chromoendoscopy | No intervention | High-definition indigo-carmine chromoendoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate
Adenoma detection rate is defined as the proportion of patients with at least one adenoma in each arm
Measured: one year
Secondary outcomes (7)
Mean of adenomas per patient
the total number of adenomas detected in each group (HD-WLE or HD-CE) divided by the number of colonoscopies in each group
Measured: one year
Mean number per patient of total polyps
Measured: one year
Mean number per patient of total serrated lesions
Measured: one year
Polyp detection rate
Measured: one year
Serrated lesions detection rate
Measured: one year
Withdrawal time
Extubation time from the cecum to scope removal from the anus, with exception of time taken for any therapeutic intervention
Measured: 30 minutes
Total procedure time
Starting with endoscope insertion and withdrawal time including therapeutic interventions
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Lynch SyndromeStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Fundacion Clinic per a la Recerca Biomédica
- Responsible party
- Principal investigator, María Pellisé, Hospital Clinic of Barcelona
- Investigators
- María Pellisé, MD. PhD., Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02951390
- Sponsor's protocol ID
- HCB/2016/0440
- Acronym
- EndoLynch
- Status last verified
- Feb 2018
- First submitted
- 28 Oct 2016
- Last updated
- 26 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Hurlstone DP, Karajeh M, Cross SS, McAlindon ME, Brown S, Hunter MD, Sanders DS. The role of high-magnification-chromoscopic colonoscopy in hereditary nonpolyposis colorectal cancer screening: a prospective "back-to-back" endoscopic study. Am J Gastroenterol. 2005 Oct;100(10):2167-73. doi: 10.1111/j.1572-0241.2005.41481.x.
PubMed 16181364Lecomte T, Cellier C, Meatchi T, Barbier JP, Cugnenc PH, Jian R, Laurent-Puig P, Landi B. Chromoendoscopic colonoscopy for detecting preneoplastic lesions in hereditary nonpolyposis colorectal cancer syndrome. Clin Gastroenterol Hepatol. 2005 Sep;3(9):897-902. doi: 10.1016/s1542-3565(05)00403-9.
PubMed 16234028Stoffel EM, Turgeon DK, Stockwell DH, Zhao L, Normolle DP, Tuck MK, Bresalier RS, Marcon NE, Baron JA, Ruffin MT, Brenner DE, Syngal S; Great Lakes-New England Clinical Epidemiology and Validation Center of the Early Detection Research Network. Missed adenomas during colonoscopic surveillance in individuals with Lynch Syndrome (hereditary nonpolyposis colorectal cancer). Cancer Prev Res (Phila). 2008 Nov;1(6):470-5. doi: 10.1158/1940-6207.CAPR-08-0098.
PubMed 19138994Huneburg R, Lammert F, Rabe C, Rahner N, Kahl P, Buttner R, Propping P, Sauerbruch T, Lamberti C. Chromocolonoscopy detects more adenomas than white light colonoscopy or narrow band imaging colonoscopy in hereditary nonpolyposis colorectal cancer screening. Endoscopy. 2009 Apr;41(4):316-22. doi: 10.1055/s-0028-1119628. Epub 2009 Apr 1.
PubMed 19340735Rahmi G, Lecomte T, Malka D, Maniere T, Le Rhun M, Guimbaud R, Lapalus MG, Le Sidaner A, Moussata D, Caron O, Barbieux JP, Gaudric M, Coron E, Barange K, Ponchon T, Sautereau D, Samaha E, Saurin JC, Chaussade S, Laurent-Puig P, Chatellier G, Cellier C. Impact of chromoscopy on adenoma detection in patients with Lynch syndrome: a prospective, multicenter, blinded, tandem colonoscopy study. Am J Gastroenterol. 2015 Feb;110(2):288-98. doi: 10.1038/ajg.2014.423. Epub 2015 Jan 20.
PubMed 25601014Rondagh EJ, Gulikers S, Gomez-Garcia EB, Vanlingen Y, Detisch Y, Winkens B, Vasen HF, Masclee AA, Sanduleanu S. Nonpolypoid colorectal neoplasms: a challenge in endoscopic surveillance of patients with Lynch syndrome. Endoscopy. 2013;45(4):257-64. doi: 10.1055/s-0032-1326195. Epub 2013 Feb 25.
PubMed 23440588Jass JR, Stewart SM. Evolution of hereditary non-polyposis colorectal cancer. Gut. 1992 Jun;33(6):783-6. doi: 10.1136/gut.33.6.783.
PubMed 1624160Rijcken FE, Hollema H, Kleibeuker JH. Proximal adenomas in hereditary non-polyposis colorectal cancer are prone to rapid malignant transformation. Gut. 2002 Mar;50(3):382-6. doi: 10.1136/gut.50.3.382.
PubMed 11839719Lindgren G, Liljegren A, Jaramillo E, Rubio C, Lindblom A. Adenoma prevalence and cancer risk in familial non-polyposis colorectal cancer. Gut. 2002 Feb;50(2):228-34. doi: 10.1136/gut.50.2.228.
PubMed 11788565Moller P, Seppala T, Bernstein I, Holinski-Feder E, Sala P, Evans DG, Lindblom A, Macrae F, Blanco I, Sijmons R, Jeffries J, Vasen H, Burn J, Nakken S, Hovig E, Rodland EA, Tharmaratnam K, de Vos Tot Nederveen Cappel WH, Hill J, Wijnen J, Green K, Lalloo F, Sunde L, Mints M, Bertario L, Pineda M, Navarro M, Morak M, Renkonen-Sinisalo L, Frayling IM, Plazzer JP, Pylvanainen K, Sampson JR, Capella G, Mecklin JP, Moslein G; Mallorca Group (http://mallorca-group.eu). Cancer incidence and survival in Lynch syndrome patients receiving colonoscopic and gynaecological surveillance: first report from the prospective Lynch syndrome database. Gut. 2017 Mar;66(3):464-472. doi: 10.1136/gutjnl-2015-309675. Epub 2015 Dec 9.
PubMed 26657901Rex DK, Cutler CS, Lemmel GT, Rahmani EY, Clark DW, Helper DJ, Lehman GA, Mark DG. Colonoscopic miss rates of adenomas determined by back-to-back colonoscopies. Gastroenterology. 1997 Jan;112(1):24-8. doi: 10.1016/s0016-5085(97)70214-2.
PubMed 8978338van Rijn JC, Reitsma JB, Stoker J, Bossuyt PM, van Deventer SJ, Dekker E. Polyp miss rate determined by tandem colonoscopy: a systematic review. Am J Gastroenterol. 2006 Feb;101(2):343-50. doi: 10.1111/j.1572-0241.2006.00390.x.
PubMed 16454841Stoffel EM, Mangu PB, Gruber SB, Hamilton SR, Kalady MF, Lau MW, Lu KH, Roach N, Limburg PJ; American Society of Clinical Oncology; European Society of Clinical Oncology. Hereditary colorectal cancer syndromes: American Society of Clinical Oncology Clinical Practice Guideline endorsement of the familial risk-colorectal cancer: European Society for Medical Oncology Clinical Practice Guidelines. J Clin Oncol. 2015 Jan 10;33(2):209-17. doi: 10.1200/JCO.2014.58.1322. Epub 2014 Dec 1.
PubMed 25452455Balmana J, Balaguer F, Cervantes A, Arnold D; ESMO Guidelines Working Group. Familial risk-colorectal cancer: ESMO Clinical Practice Guidelines. Ann Oncol. 2013 Oct;24 Suppl 6:vi73-80. doi: 10.1093/annonc/mdt209. Epub 2013 Jun 27. No abstract available.
PubMed 23813931Vasen HF, Abdirahman M, Brohet R, Langers AM, Kleibeuker JH, van Kouwen M, Koornstra JJ, Boot H, Cats A, Dekker E, Sanduleanu S, Poley JW, Hardwick JC, de Vos Tot Nederveen Cappel WH, van der Meulen-de Jong AE, Tan TG, Jacobs MA, Mohamed FL, de Boer SY, van de Meeberg PC, Verhulst ML, Salemans JM, van Bentem N, Westerveld BD, Vecht J, Nagengast FM. One to 2-year surveillance intervals reduce risk of colorectal cancer in families with Lynch syndrome. Gastroenterology. 2010 Jun;138(7):2300-6. doi: 10.1053/j.gastro.2010.02.053. Epub 2010 Mar 2.
PubMed 20206180
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Definition White-Light Colonoscopy Versus Chromoendoscopy for Surveillance of Lynch Syndrome. A Prospective, Multicenter and Randomized Study
- ClinicalTrials.gov ID
- NCT02951390
- Acronym / sponsor ID
- EndoLynch / HCB/2016/0440
- Conditions
- Lynch Syndrome
- Keywords
- Surveillance, Colorectal cancer, Colonoscopy, Adenoma, Chromoendoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Fundacion Clinic per a la Recerca Biomédica
- Study start
- Jul 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 1 Nov 2016 (estimated)
- 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.
Adenomas in Lynch syndrome have an accelerated progression to colorectal cancer (CRC) which might occur despite a regular follow-up. Despite low evidence, high-definition technology (HD) and indigo-carmine chromoendoscopy (CE) are recommended for surveillance in Lynch syndrome.The investigators will conduct a prospective multicenter randomized non-inferiority study. The principal aim is to compare the adenoma detection rate with WLE vs CE. Our hypothesis is that HD-white-light endoscopy (WLE) is not inferior to CE. Therefore - under expert hands - HD-CE does not add any significant advantage over HD-WLE on adenoma detection rate in patients with Lynch syndrome.
Detailed description
The investigators will conduct a prospective multicenter randomized non-inferiority study. Eligible patients will be those with Lynch syndrome (known germline mutation in mismatch repair genes) who undergo surveillance colonoscopies. Patients will be sequentially assigned in a 1:1 ratio to HD-WLE or HD-CE. The method of stratified randomization based on partial colectomy history will be used to avoid proportion imbalance between groups. Participant centers must have an organized high-risk of CRC clinic and endoscopic unit provided with HD technology. Endoscopists must have a documented high adenoma detection rate and experience in performing CE in patients with high-risk conditions of CRC.
The principal aim is to compare the adenoma detection rate with WLE vs CE. Principal outcome measures will be: 1) adenoma detection rate, defined as the proportion of patients with at least one adenoma in each arm; 2) number of adenomas per patient, defined as the total number of detected adenomas in each arm (HD-WLE or HD-CE) divided by the number of colonoscopies in each arm.
The sample size calculation was determined for a non-inferiority study. Assuming an ADR of 28% with conventional chromoendoscopy in patients with Lynch syndrome, a 15% non-inferiority margin, a one-sided significance level of 0.05 powered at 80% and a 10% of drop-off. Based on these assumptions, it was determined that 122 patients were required for each arm (a total of 244).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-definition white-light endoscopy | Active comparator | Other: High-definition white-light endoscopyHigh-definition white-light endoscopy without indigo carmine instilation |
| High-definition chromoendoscopy | No intervention | –High-definition indigo-carmine chromoendoscopy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with proven pathologic germline mutation in one of the mismatch-repair (MMR) gene (MLH1, MSH2, MSH6, PMS2 or Epcam) who will undergo surveillance colonoscopy
Key exclusion criteria (6 listed)
- Patients with total colectomy
- Concomitant inflammatory bowel disease
- Inadequate bowel preparation (Boston scale <2 in any colonic segment)
- Incomplete procedure (without intubation of cecum or ileo-colonic anastomosis)
- Previous colonoscopy in less than one year
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 |
|---|---|---|
| High-definition white-light endoscopyThe intervention is do not perform chromoendoscopy | Other | High-definition white-light endoscopy |
Primary outcome
Adenoma detection rate
Time frame: one year
Adenoma detection rate is defined as the proportion of patients with at least one adenoma in each arm
7 secondary outcomes
Mean of adenomas per patient
Time frame: one year
Mean number per patient of total polyps
Time frame: one year
Mean number per patient of total serrated lesions
Time frame: one year
Polyp detection rate
Time frame: one year
Serrated lesions detection rate
Time frame: one year
Withdrawal time
Time frame: 30 minutes
Total procedure time
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2018.
- Background: PubMed 16181364Hurlstone DP, Karajeh M, Cross SS, McAlindon ME, Brown S, Hunter MD, Sanders DS. The role of high-magnification-chromoscopic colonoscopy in hereditary nonpolyposis colorectal cancer screening: a prospective "back-to-back" endoscopic study. Am J Gastroenterol. 2005 Oct;100(10):2167-73. doi: 10.1111/j.1572-0241.2005.41481.x.
- Background: PubMed 16234028Lecomte T, Cellier C, Meatchi T, Barbier JP, Cugnenc PH, Jian R, Laurent-Puig P, Landi B. Chromoendoscopic colonoscopy for detecting preneoplastic lesions in hereditary nonpolyposis colorectal cancer syndrome. Clin Gastroenterol Hepatol. 2005 Sep;3(9):897-902. doi: 10.1016/s1542-3565(05)00403-9.
- Background: PubMed 19138994Stoffel EM, Turgeon DK, Stockwell DH, Zhao L, Normolle DP, Tuck MK, Bresalier RS, Marcon NE, Baron JA, Ruffin MT, Brenner DE, Syngal S; Great Lakes-New England Clinical Epidemiology and Validation Center of the Early Detection Research Network. Missed adenomas during colonoscopic surveillance in individuals with Lynch Syndrome (hereditary nonpolyposis colorectal cancer). Cancer Prev Res (Phila). 2008 Nov;1(6):470-5. doi: 10.1158/1940-6207.CAPR-08-0098.
- Background: PubMed 19340735Huneburg R, Lammert F, Rabe C, Rahner N, Kahl P, Buttner R, Propping P, Sauerbruch T, Lamberti C. Chromocolonoscopy detects more adenomas than white light colonoscopy or narrow band imaging colonoscopy in hereditary nonpolyposis colorectal cancer screening. Endoscopy. 2009 Apr;41(4):316-22. doi: 10.1055/s-0028-1119628. Epub 2009 Apr 1.
- Background: PubMed 25601014Rahmi G, Lecomte T, Malka D, Maniere T, Le Rhun M, Guimbaud R, Lapalus MG, Le Sidaner A, Moussata D, Caron O, Barbieux JP, Gaudric M, Coron E, Barange K, Ponchon T, Sautereau D, Samaha E, Saurin JC, Chaussade S, Laurent-Puig P, Chatellier G, Cellier C. Impact of chromoscopy on adenoma detection in patients with Lynch syndrome: a prospective, multicenter, blinded, tandem colonoscopy study. Am J Gastroenterol. 2015 Feb;110(2):288-98. doi: 10.1038/ajg.2014.423. Epub 2015 Jan 20.
- Background: PubMed 23440588Rondagh EJ, Gulikers S, Gomez-Garcia EB, Vanlingen Y, Detisch Y, Winkens B, Vasen HF, Masclee AA, Sanduleanu S. Nonpolypoid colorectal neoplasms: a challenge in endoscopic surveillance of patients with Lynch syndrome. Endoscopy. 2013;45(4):257-64. doi: 10.1055/s-0032-1326195. Epub 2013 Feb 25.
- Background: PubMed 1624160Jass JR, Stewart SM. Evolution of hereditary non-polyposis colorectal cancer. Gut. 1992 Jun;33(6):783-6. doi: 10.1136/gut.33.6.783.
- Background: PubMed 11839719Rijcken FE, Hollema H, Kleibeuker JH. Proximal adenomas in hereditary non-polyposis colorectal cancer are prone to rapid malignant transformation. Gut. 2002 Mar;50(3):382-6. doi: 10.1136/gut.50.3.382.
- Background: PubMed 11788565Lindgren G, Liljegren A, Jaramillo E, Rubio C, Lindblom A. Adenoma prevalence and cancer risk in familial non-polyposis colorectal cancer. Gut. 2002 Feb;50(2):228-34. doi: 10.1136/gut.50.2.228.
- Background: PubMed 26657901Moller P, Seppala T, Bernstein I, Holinski-Feder E, Sala P, Evans DG, Lindblom A, Macrae F, Blanco I, Sijmons R, Jeffries J, Vasen H, Burn J, Nakken S, Hovig E, Rodland EA, Tharmaratnam K, de Vos Tot Nederveen Cappel WH, Hill J, Wijnen J, Green K, Lalloo F, Sunde L, Mints M, Bertario L, Pineda M, Navarro M, Morak M, Renkonen-Sinisalo L, Frayling IM, Plazzer JP, Pylvanainen K, Sampson JR, Capella G, Mecklin JP, Moslein G; Mallorca Group (http://mallorca-group.eu). Cancer incidence and survival in Lynch syndrome patients receiving colonoscopic and gynaecological surveillance: first report from the prospective Lynch syndrome database. Gut. 2017 Mar;66(3):464-472. doi: 10.1136/gutjnl-2015-309675. Epub 2015 Dec 9.
- Background: PubMed 8978338Rex DK, Cutler CS, Lemmel GT, Rahmani EY, Clark DW, Helper DJ, Lehman GA, Mark DG. Colonoscopic miss rates of adenomas determined by back-to-back colonoscopies. Gastroenterology. 1997 Jan;112(1):24-8. doi: 10.1016/s0016-5085(97)70214-2.
- Background: PubMed 16454841van Rijn JC, Reitsma JB, Stoker J, Bossuyt PM, van Deventer SJ, Dekker E. Polyp miss rate determined by tandem colonoscopy: a systematic review. Am J Gastroenterol. 2006 Feb;101(2):343-50. doi: 10.1111/j.1572-0241.2006.00390.x.
- 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.
María Pellisé, MD. PhD. principal investigator
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-definition white-light endoscopy in people with Lynch Syndrome, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 26 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adenoma detection rate (time frame: one year). 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 NCT02951390, which also lists 21 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 26 Feb 2018.