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Colorectal CancerEpiT1NCT04150081

Endoscopic Versus Surgical Treatment for T1 Colorectal Cancer

An observational study of Colorectal Cancer, run by Hospital Clinic of Barcelona at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The implementation of population screening programs for colorectal cancer (CRC) has led to a considerable increase in the prevalence T1 CRC originating on polyps amenable by endoscopy. The benefits of secondary oncological surgery in terms of disease free survival are not well established. Read more about this study

Who is it for?
Any age
Conditions the study is for
Colorectal Cancer
What is being tested?
Surgery or Endoscopic treatment
Type of treatment
Surgery or procedure
How many people
1,400 participants
Where
1 siteSpain
Study dates
1 Nov 2019to 31 Dec 2022
Phase
Observational
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Spanish multicenter observational retrospective cohort study where all cases of pT1 CRC will be included from January 2007 to December 2017. Patients will be included both inside and outside the CCR national screening program.

Who may be able to join

  • All patients diagnosed with pT1 CRC will be included, regardless of endoscopic features, treatment received and lymph node staging

Who cannot join

  • CRC with other histology than adenocarcinoma
  • Patients with hereditary syndromes of CRC (Lynch syndrome, classical familial adenomatous polyposis) or inflammatory bowel disease.
  • Synchronous CRC
  • Metachronous CRC in the previous 5 years
  • Patients with metastatic neoplastic disease at the time of diagnosis

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • María Pellisé. MD. PhD.

    Barcelona, 08036

Other trials in Spain

About this study

Official title: Endoscopic Versus Surgical Treatment for T1 Colorectal Cancer: a Population-based Cohort Study

The implementation of population screening programs for colorectal cancer (CRC) has led to a considerable increase in the prevalence T1 CRC originating on polyps amenable by endoscopy. The benefits of secondary oncological surgery in terms of disease free survival are not well established.

Hypothesis: The characteristics of the individuals and the polyp (endoscopic, histological) should allow us to discriminate T1 CRCs that may benefit from secondary surgery from those that only require local treatment. With the current criteria, the management of patients with T1 CRC is suboptimal since a high proportion of patients are refered for unnecessary surgeries without a clear benefit in terms of survival. Molecular signatures can help to discriminate those patients with good prognosis that do not require secondary surgery nor cancer related follow up.

Read the detailed description

The primary objective of the study is to compare the effect of oncological surgery versus local treatment for the management of polyps with T1 CRC in relation to disease-free survival and morbi-mortality of the therapeutic procedure. We will also validate molecular signatures in endoscopic samples for the prediction of lymph node metastasis and survival. Methodology: Clinical Study: Retrospective population-based cohort study that will include baseline clinical and follow up data of more than 1400 T1 CRCs in at least 10 Spanish autonomous communities from 2007 to 2017. A centralized pathological review will be carried out by a group of expert pathologists. Inter and intraobserver variability for histological staging will be assessed. A predictive model will be created to discriminate individuals with high probability of receiving surgical and local treatment. For those patients who have a similar probability range, the results in progression-free survival and adverse events will be compared. Translational phase: A 5miRNAs and 8mRNA signature predictive of lymph node metastasis will be assessed in 200 endoscopic samples and related with prognosis.

Being tested
Surgery or Endoscopic treatment
Keywords
T1 Colorectal Cancer, Early Colorectal Cancer, Endoscopic polypectomy, Oncological Surgery, Lymph node metastasis, Molecular signatures, Disease free survival
Medical subject headings
Colorectal Neoplasms, Lymphatic Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Surgery or Endoscopic treatmentProcedure or surgery

    All the patients in the cohort will receive surgery o local (endoscopic) treatment, in some cases additional surgical treatment will be performed after an endoscopic primary treatment. This decision will have been taken based on daily clinical practice and does not represent a study intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    Evaluate the effect of surgery and local (endoscopic) treatment on overall survival (expressed in months)

    Measured: 1 year

  2. Disease free survival

    Evaluate the effect of surgery and local (endoscopic) treatment on disease free survival (expressed in months)

    Measured: 1 year

  3. Develop a predictive model of the probability of receiving surgical treatment

    Determine factors associated with the choice of primary treatment and final treatment (endoscopic, primary surgery or secondary surgery) and to develop a predictive model that allow discriminate individuals with high probability of receiving surgical treatment

    Measured: 1 year

  4. Validation of molecular signatures

    Evaluate the validity of molecular signatures based on mRNA and miRNA (determined in endoscopic samples) for prediction lymph node metastasis

    Measured: 2 years

Secondary outcomes (6)

  1. Prognosis

    Determine the prognosis of patients with pT1CRC in relation to the treatment received (local, primary surgery or secondary surgery)

    Measured: 1 year

  2. Risk of lymph node metastasis

    Evaluate the factors of the individual and the polyp that are associated with lymph node metastasis

    Measured: 1 year

  3. Concordance of histological evaluation

    Evaluate the inter-intraexplorer concordance of the pathologists for the histological staging criteria.

    Measured: 2 years

  4. T1 CRC in screening program

    Compare the characteristics of the T1 CRCs diagnosed within a population screening program and outside it.

    Measured: 1 year

  5. Proportion of adverse events

    Evaluate the proportion of adverse effects after endoscopic or surgical treatment

    Measured: 1 year

  6. Sensitivity and specificity of follow-up tests

    To evaluate the performances of the different tests (CT, US, blood markers, colonoscopy) during follow up for detecting recurrence

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2019
  2. Study start1 Nov 2019
  3. Primary completion1 May 2021
  4. Study completion31 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
1,400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04150081
Sponsor's protocol ID
HCB/2019/0224
Acronym
EpiT1
Status last verified
Mar 2022
First submitted
17 Oct 2019
Last updated
17 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Logan RF, Patnick J, Nickerson C, Coleman L, Rutter MD, von Wagner C; English Bowel Cancer Screening Evaluation Committee. Outcomes of the Bowel Cancer Screening Programme (BCSP) in England after the first 1 million tests. Gut. 2012 Oct;61(10):1439-46. doi: 10.1136/gutjnl-2011-300843. Epub 2011 Dec 7.

    PubMed 22156981

  • Williams JG, Pullan RD, Hill J, Horgan PG, Salmo E, Buchanan GN, Rasheed S, McGee SG, Haboubi N; Association of Coloproctology of Great Britain and Ireland. Management of the malignant colorectal polyp: ACPGBI position statement. Colorectal Dis. 2013 Aug;15 Suppl 2:1-38. doi: 10.1111/codi.12262. No abstract available.

    PubMed 23848492

  • Ueno H, Mochizuki H, Hashiguchi Y, Shimazaki H, Aida S, Hase K, Matsukuma S, Kanai T, Kurihara H, Ozawa K, Yoshimura K, Bekku S. Risk factors for an adverse outcome in early invasive colorectal carcinoma. Gastroenterology. 2004 Aug;127(2):385-94. doi: 10.1053/j.gastro.2004.04.022.

    PubMed 15300569

  • Hashiguchi Y, Muro K, Saito Y, Ito Y, Ajioka Y, Hamaguchi T, Hasegawa K, Hotta K, Ishida H, Ishiguro M, Ishihara S, Kanemitsu Y, Kinugasa Y, Murofushi K, Nakajima TE, Oka S, Tanaka T, Taniguchi H, Tsuji A, Uehara K, Ueno H, Yamanaka T, Yamazaki K, Yoshida M, Yoshino T, Itabashi M, Sakamaki K, Sano K, Shimada Y, Tanaka S, Uetake H, Yamaguchi S, Yamaguchi N, Kobayashi H, Matsuda K, Kotake K, Sugihara K; Japanese Society for Cancer of the Colon and Rectum. Japanese Society for Cancer of the Colon and Rectum (JSCCR) guidelines 2019 for the treatment of colorectal cancer. Int J Clin Oncol. 2020 Jan;25(1):1-42. doi: 10.1007/s10147-019-01485-z. Epub 2019 Jun 15.

    PubMed 31203527

  • Benson AB, Venook AP, Al-Hawary MM, Cederquist L, Chen YJ, Ciombor KK, Cohen S, Cooper HS, Deming D, Engstrom PF, Garrido-Laguna I, Grem JL, Grothey A, Hochster HS, Hoffe S, Hunt S, Kamel A, Kirilcuk N, Krishnamurthi S, Messersmith WA, Meyerhardt J, Miller ED, Mulcahy MF, Murphy JD, Nurkin S, Saltz L, Sharma S, Shibata D, Skibber JM, Sofocleous CT, Stoffel EM, Stotsky-Himelfarb E, Willett CG, Wuthrick E, Gregory KM, Freedman-Cass DA. NCCN Guidelines Insights: Colon Cancer, Version 2.2018. J Natl Compr Canc Netw. 2018 Apr;16(4):359-369. doi: 10.6004/jnccn.2018.0021.

    PubMed 29632055

  • Glynne-Jones R, Wyrwicz L, Tiret E, Brown G, Rodel C, Cervantes A, Arnold D; ESMO Guidelines Committee. Rectal cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2017 Jul 1;28(suppl_4):iv22-iv40. doi: 10.1093/annonc/mdx224. No abstract available.

    PubMed 28881920

  • Belderbos TD, van Erning FN, de Hingh IH, van Oijen MG, Lemmens VE, Siersema PD. Long-term Recurrence-free Survival After Standard Endoscopic Resection Versus Surgical Resection of Submucosal Invasive Colorectal Cancer: A Population-based Study. Clin Gastroenterol Hepatol. 2017 Mar;15(3):403-411.e1. doi: 10.1016/j.cgh.2016.08.041. Epub 2016 Sep 5.

    PubMed 27609703

  • Hassan C, Zullo A, Risio M, Rossini FP, Morini S. Histologic risk factors and clinical outcome in colorectal malignant polyp: a pooled-data analysis. Dis Colon Rectum. 2005 Aug;48(8):1588-96. doi: 10.1007/s10350-005-0063-3.

    PubMed 15937622

  • Beaton C, Twine CP, Williams GL, Radcliffe AG. Systematic review and meta-analysis of histopathological factors influencing the risk of lymph node metastasis in early colorectal cancer. Colorectal Dis. 2013 Jul;15(7):788-97. doi: 10.1111/codi.12129.

    PubMed 23331927

  • Yoda Y, Ikematsu H, Matsuda T, Yamaguchi Y, Hotta K, Kobayashi N, Fujii T, Oono Y, Sakamoto T, Nakajima T, Takao M, Shinohara T, Fujimori T, Kaneko K, Saito Y. A large-scale multicenter study of long-term outcomes after endoscopic resection for submucosal invasive colorectal cancer. Endoscopy. 2013 Sep;45(9):718-24. doi: 10.1055/s-0033-1344234. Epub 2013 Aug 5.

    PubMed 23918621

  • Lopez A, Bouvier AM, Jooste V, Cottet V, Romain G, Faivre J, Manfredi S, Lepage C. Outcomes following polypectomy for malignant colorectal polyps are similar to those following surgery in the general population. Gut. 2019 Jan;68(1):111-117. doi: 10.1136/gutjnl-2016-312093. Epub 2017 Oct 26.

    PubMed 29074726

  • Ozawa T, Kandimalla R, Gao F, Nozawa H, Hata K, Nagata H, Okada S, Izumi D, Baba H, Fleshman J, Wang X, Watanabe T, Goel A. A MicroRNA Signature Associated With Metastasis of T1 Colorectal Cancers to Lymph Nodes. Gastroenterology. 2018 Mar;154(4):844-848.e7. doi: 10.1053/j.gastro.2017.11.275. Epub 2017 Dec 2.

    PubMed 29199088

  • Backes Y, de Vos Tot Nederveen Cappel WH, van Bergeijk J, Ter Borg F, Schwartz MP, Spanier BWM, Geesing JMJ, Kessels K, Kerkhof M, Groen JN, Wolfhagen FHJ, Seerden TCJ, van Lelyveld N, Offerhaus GJA, Siersema PD, Lacle MM, Moons LMG. Risk for Incomplete Resection after Macroscopic Radical Endoscopic Resection of T1 Colorectal Cancer: A Multicenter Cohort Study. Am J Gastroenterol. 2017 May;112(5):785-796. doi: 10.1038/ajg.2017.58. Epub 2017 Mar 21.

    PubMed 28323275

  • Richards CH, Ventham NT, Mansouri D, Wilson M, Ramsay G, Mackay CD, Parnaby CN, Smith D, On J, Speake D, McFarlane G, Neo YN, Aitken E, Forrest C, Knight K, McKay A, Nair H, Mulholland C, Robertson JH, Carey FA, Steele R; Scottish Surgical Research Group. An evidence-based treatment algorithm for colorectal polyp cancers: results from the Scottish Screen-detected Polyp Cancer Study (SSPoCS). Gut. 2018 Feb;67(2):299-306. doi: 10.1136/gutjnl-2016-312201. Epub 2016 Oct 27.

    PubMed 27789658

  • Overwater A, Kessels K, Elias SG, Backes Y, Spanier BWM, Seerden TCJ, Pullens HJM, de Vos Tot Nederveen Cappel WH, van den Blink A, Offerhaus GJA, van Bergeijk J, Kerkhof M, Geesing JMJ, Groen JN, van Lelyveld N, Ter Borg F, Wolfhagen F, Siersema PD, Lacle MM, Moons LMG; Dutch T1 CRC Working Group. Endoscopic resection of high-risk T1 colorectal carcinoma prior to surgical resection has no adverse effect on long-term outcomes. Gut. 2018 Feb;67(2):284-290. doi: 10.1136/gutjnl-2015-310961. Epub 2016 Nov 3.

    PubMed 27811313

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Cancer, 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 5 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: status not confirmed, as of the sponsor's last update on 17 Mar 2022. 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?

Results are not available in the source record.

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?

Overall survival (time frame: 1 year). The study lists 4 primary outcomes in all. 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 NCT04150081, which also lists 16 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 17 Mar 2022.

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