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Noncurative Endoscopic Resection of Colorectal Adenocarcinoma (NoncurativeESD)

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ClinicalTrials.gov Identifier: NCT03987828
Recruitment Status : Not yet recruiting
First Posted : June 17, 2019
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Istituto Clinico Humanitas

Tracking Information
First Submitted Date June 11, 2019
First Posted Date June 17, 2019
Last Update Posted Date July 24, 2019
Estimated Study Start Date July 31, 2019
Estimated Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 14, 2019)
Survival [ Time Frame: 6 Months ]
Overall survival cancer-specific survival and disease-free survival rate after noncurative ESD.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03987828 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Noncurative Endoscopic Resection of Colorectal Adenocarcinoma
Official Title Long-term Outcomes After Noncurative Endoscopic Resection of Colorectal Adenocarcinoma
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 Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
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.

Condition Noncurative Resection
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: June 14, 2019)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 30, 2019
Estimated Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Alessandro Repici, MD 0039-02-82247493 alessandro.repici@hunimed.eu
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03987828
Other Study ID Numbers Non_curativeESD
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Istituto Clinico Humanitas
Study Sponsor Istituto Clinico Humanitas
Collaborators Not Provided
Investigators Not Provided
PRS Account Istituto Clinico Humanitas
Verification Date July 2019