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AzTrials

Colorectal CancerLST GMNCT03836131

Rate of Cancer of Granular Mixed Laterally Spreading Tumors (GM-LST)

An observational study of Colorectal Cancer, run by Istituto Clinico Humanitas at 2 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Colorectal cancer (CRC) is the third most common cancer in men and the second in women worldwide, with 1.65 million new cases and almost 835,000 deaths in 2015. CRC is still a major cause of mortality associated with cancer, although the wide spread of the screening program has led to a reduction in the mortality rate… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
How many people
2,000 participants
Where
2 sitesItaly
Study dates
31 Dec 2018to 31 Jan 2020
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: This is a multicenter retrospective observational study. All consecutive patients with GM-LST, who underwent endoscopic resection from, will be enrolled in the study. For each procedure LST size, nodule size, location, type of technique used for removal (EMR, ESD, hybrid ESD), type of removal (piecemeal or en bloc), histological examination, possible surgical intervention (and attached histological examination of the operative piece) and possible relapses will be reported.

Who may be able to join

  • Age ≥18 years
  • LST-GM defined according to Paris classification
  • Agree to receive follow up phone calls

Who cannot join

  • Evidence of familial adenomatous polyposis or inflammatory bowel diseases
  • Deep submucosal invasion diagnosed by distorted pit pattern (Kudo's type V)
  • Poor general clinical condition (American Society of Anesthesiologists score ≥3)
  • Coagulation disorders
  • Pregnancy and breastfeeding

Trial locations and contacts

2 sites in 1 country.

Italy2 sites
  • Humanitas Research Hospital

    Milan, 20089

  • Humanitas Research Hospital

    Rozzano, 20089

Other trials in Italy

About this study

Official title: Rate of Cancer of Granular Mixed Laterally Spreading Tumors (GM-LST): A Restrospective Multicentric Analysis

Colorectal cancer (CRC) is the third most common cancer in men and the second in women worldwide, with 1.65 million new cases and almost 835,000 deaths in 2015. CRC is still a major cause of mortality associated with cancer, although the wide spread of the screening program has led to a reduction in the mortality rate compared to the last decades.

CRCs derive from precancerous lesions that may be polypoid or non-polypoid according to the Paris classification. Thus, resection in an early stage could led to a CRC mortality reduction.

Read more

Laterally spreading tumors (LST) are non-polypoid lesions of at least 1 cm in diameter that have lateral growth rather than upward or downward growth.

The prevalence of LSTs ranges from 1 to 6% of all colorectal lesions. LSTs can be divided into two groups: granular LSTs, which include homogeneous and granular mixed forms and non-granular (NG) LSTs, which include pseudo-depressed and flat-elevated forms.

Histologically, 90% of LSTs are adenomas and having a low incidence of invasive neoplasia, these lesions can be removed endoscopically.

However, as evidenced by a recent meta-analysis published by Bogie Roel MM et al on Endoscopy, the type of LST and the distal or proximal colonic localization could represent predictors of submucosal invasion and could simplify the therapeutic decision for the removal of these lesions. GM-LSTs and pseudo-depressed NG-LSTs predominantly localize in the distal portion of the colon and have a submucosal invasion rate of 10,5% and 31,6% respectively.

LSTs can be removed both through endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD). The main limitation of EMR is that large lesions require a piecemeal approach, resulting in a non-optimal histological evaluation and a high risk of recurrence. ESD instead allows a higher rate of en bloc resections, thus resulting more curative and reducing the risk of having partial and incomplete resections, which can lead to disease recurrence/non curative resection.

LST-GM are characterized by the presence of a granular appearance with a main nodule and represent approximately 1/4 of the LSTs. There are no guidelines indicating the proper resective technique of these lesions.

The European Society of Gastrointestinal Endoscopy (ESGE) suggests to consider ESD for the removal of colorectal lesions that are > 20 mm in size, with a depressed and irregular morphology or a non-granular surface pattern, as these lesions have a high probability of having a limited submucosal invasion. Moreover ESD can be used to treat lesions that cannot be completely removed with standard polypectomy or EMR.

The investigators propose to perform a multicenter retrospective observational study to define the percentage of cancer in patients with GM-LSTs treated with endoscopic resection in order to evaluate the correlation between pre-resection and post-resection characteristics, defining the best therapeutic approach (en bloc or piecemeal) and avoiding incomplete endoscopic resections or unnecessary surgical procedures.

Medical subject headings
Colorectal Neoplasms

What is being measured

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

  1. The percentage of cancer in patients with GM-LSTs treated with endoscopic resection.

    Measured: 12 Months

Timeline

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

  1. First posted11 Feb 2019
  2. Study start31 Dec 2018
  3. Primary completion31 Jan 2020
  4. Study completion31 Jan 2020

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
2,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03836131
Sponsor's protocol ID
767
Acronym
LST GM
Status last verified
Feb 2020
First submitted
8 Feb 2019
Last updated
12 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • D'Amico F, Amato A, Iannone A, Trovato C, Romana C, Angeletti S, Maselli R, Radaelli F, Fiori G, Viale E, Di Giulio E, Soriani P, Manno M, Rondonotti E, Galtieri PA, Anderloni A, Fugazza A, Ferrara EC, Carrara S, Di Leo M, Pellegatta G, Spadaccini M, Lamonaca L, Craviotto V, Belletrutti PJ, Hassan C, Repici A; Bowell Group. Risk of Covert Submucosal Cancer in Patients With Granular Mixed Laterally Spreading Tumors. Clin Gastroenterol Hepatol. 2021 Jul;19(7):1395-1401. doi: 10.1016/j.cgh.2020.07.024. Epub 2020 Jul 17.

    PubMed 32687977

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Cancer, run by Istituto Clinico Humanitas at 2 sites in Italy.

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 3 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: finished, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. 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?

The percentage of cancer in patients with GM-LSTs treated with endoscopic resection. (time frame: 12 Months). 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 NCT03836131, which also lists 1 linked publication.

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 12 Feb 2020.

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