Noncurative ResectionNoncurativeESDNCT03987828
Noncurative Endoscopic Resection of Colorectal Adenocarcinoma
An observational study of Noncurative Resection, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
Patients with noncurative resection after ESD for CRC were considered for additional surgical treatment. Then, they either underwent surgery with curative intent or did not, according to patients choice and surgeons indication / contraindication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Noncurative Resection
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2019to 31 Dec 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: Patients who underwent a non-curative colorectal endoscopic submucosal dissection (ESD). Curative resection was defined as follows: en bloc resection (tumor removal in one piece without fragmentation) and R0 resection (negative horizontal and vertical resected margins) of a neoplastic (adenocarcinoma) lesion with no lymphovascular infiltration (LVI), no budding, no undifferentiated tumor (G3), no deep invasion (T1 sm3 or deeper). Patients are required to meet none of the exclusion criteria.
Who may be able to join
- undergoing non-curative colorectal endoscopic submucosal dissection (ESD).
Who cannot join
- Histology other than cancer (adenocarcinoma).
- History of inflammatory bowel disease (IBD).
- Genetic conditions predisposing to CR.
- Lost to follow up or less than 6 months of follow up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Outcomes After Noncurative Endoscopic Resection of Colorectal Adenocarcinoma
Patients with noncurative resection after ESD for CRC were considered for additional surgical treatment. Then, they either underwent surgery with curative intent or did not, according to patients choice and surgeons indication / contraindication.
We performed a retrospective revision of outcome data by clinical report review or phone calls.
Read the detailed description
Patients with noncurative resection after ESD for CRC were considered for additional surgical treatment. Then, they either underwent surgery with curative intent or did not, according to patients choice and surgeons indication / contraindication.
We performed a retrospective revision of outcome data by clinical report review or phone calls.
- Conditions
- Noncurative Resection
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Overall survival cancer-specific survival and disease-free survival rate after noncurative ESD.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start1 Sep 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Noncurative ResectionStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03987828
- Sponsor's protocol ID
- Non_curativeESD
- Acronym
- NoncurativeESD
- Status last verified
- Mar 2021
- First submitted
- 11 Jun 2019
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Spadaccini M, Bourke MJ, Maselli R, Pioche M, Bhandari P, Jacques J, Haji A, Yang D, Albeniz E, Kaminski MF, Messmann H, Herreros de Tejada A, Sferrazza S, Pekarek B, Rivory J, Geyl S, Gulati S, Draganov P, Shahidi N, Hossain E, Fleischmann C, Vespa E, Iannone A, Alkandari A, Hassan C, Repici A; ESD Western Alliance (EWA). Clinical outcome of non-curative endoscopic submucosal dissection for early colorectal cancer. Gut. 2022 Sep 7;71(10):1998-2004. doi: 10.1136/gutjnl-2020-323897.
PubMed 35058275
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcomes After Noncurative Endoscopic Resection of Colorectal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT03987828
- Acronym / sponsor ID
- NoncurativeESD / Non_curativeESD
- Conditions
- Noncurative Resection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 17 Jun 2019 (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.
Patients with noncurative resection after ESD for CRC were considered for additional surgical treatment. Then, they either underwent surgery with curative intent or did not, according to patients choice and surgeons indication / contraindication.
We performed a retrospective revision of outcome data by clinical report review or phone calls.
Detailed description
Patients with noncurative resection after ESD for CRC were considered for additional surgical treatment. Then, they either underwent surgery with curative intent or did not, according to patients choice and surgeons indication / contraindication.
We performed a retrospective revision of outcome data by clinical report review or phone calls.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent a non-curative colorectal endoscopic submucosal dissection (ESD). Curative resection was defined as follows: en bloc resection (tumor removal in one piece without fragmentation) and R0 resection (negative horizontal and vertical resected margins) of a neoplastic (adenocarcinoma) lesion with no lymphovascular infiltration (LVI), no budding, no undifferentiated tumor (G3), no deep invasion (T1 sm3 or deeper). Patients are required to meet none of the exclusion criteria.
Key inclusion criteria (1 listed)
- undergoing non-curative colorectal endoscopic submucosal dissection (ESD).
Key exclusion criteria (4 listed)
- Histology other than cancer (adenocarcinoma).
- History of inflammatory bowel disease (IBD).
- Genetic conditions predisposing to CR.
- Lost to follow up or less than 6 months of follow up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival
Time frame: 6 Months
Overall survival cancer-specific survival and disease-free survival rate after noncurative ESD.
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 18 Mar 2021.
- Derived from this study: PubMed 35058275Spadaccini M, Bourke MJ, Maselli R, Pioche M, Bhandari P, Jacques J, Haji A, Yang D, Albeniz E, Kaminski MF, Messmann H, Herreros de Tejada A, Sferrazza S, Pekarek B, Rivory J, Geyl S, Gulati S, Draganov P, Shahidi N, Hossain E, Fleischmann C, Vespa E, Iannone A, Alkandari A, Hassan C, Repici A; ESD Western Alliance (EWA). Clinical outcome of non-curative endoscopic submucosal dissection for early colorectal cancer. Gut. 2022 Sep 7;71(10):1998-2004. doi: 10.1136/gutjnl-2020-323897.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Noncurative Resection, run by Istituto Clinico Humanitas at 1 site 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 1 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: finished, as of the sponsor's last update on 18 Mar 2021. 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 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?
Survival (time frame: 6 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 NCT03987828, 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 18 Mar 2021.