Noncurative Endoscopic Resection of Colorectal Adenocarci... | NCT03987828

Studies
Noncurative Endoscopic Resection of Colorectal Adenocarcinoma

NCT03987828

Sponsor

Istituto Clinico Humanitas

Status

Completed

Last Update Posted

Mar 18, 2021Actual

Enrollment

500Actual

Phase

Not provided

Conditions

Noncurative Resection

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2019Actual

Primary Completion Date

Dec 31, 2020Actual

Completion Date

Dec 31, 2020Actual

First Submitted Date

Jun 11, 2019

First Submission Date that Met QC Criteria

Jun 14, 2019

First Posted Date

Jun 17, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2021

Last Update Posted Date

Mar 18, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

We performed a retrospective revision of outcome data by clinical report review or phone calls.

Detailed Description

We performed a retrospective revision of outcome data by clinical report review or phone calls.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Survival	Overall survival cancer-specific survival and disease-free survival rate after noncurative ESD.	6 Months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- undergoing non-curative colorectal endoscopic submucosal dissection (ESD).

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Endoscopy Unit, Humanitas Research Hospital		Rozzano	Milano	20089	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35058275	Derived	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.