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Noncurative Endoscopic Resection of Colorectal Adenocarcinoma (NoncurativeESD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03987828
Recruitment Status : Recruiting
First Posted : June 17, 2019
Last Update Posted : February 13, 2020
Sponsor:
Information provided by (Responsible Party):
Istituto Clinico Humanitas

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.


Condition or disease
Noncurative Resection

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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Long-term Outcomes After Noncurative Endoscopic Resection of Colorectal Adenocarcinoma
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : February 29, 2020
Estimated Study Completion Date : February 29, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy




Primary Outcome Measures :
  1. Survival [ Time Frame: 6 Months ]
    Overall survival cancer-specific survival and disease-free survival rate after noncurative ESD.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987828


Contacts
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Contact: Alessandro Repici, MD 0039-02-82247493 alessandro.repici@hunimed.eu

Locations
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Italy
Endoscopy Unit, Humanitas Research Hospital Recruiting
Rozzano, Milano, Italy, 20089
Contact: Alessandro Repici, MD    +39282247493    alessandro.repici@humanitas.it   
Principal Investigator: Alessandro Repici, MD         
Sub-Investigator: Silvia Carrara, MD         
Sub-Investigator: Andrea Anderloni, MD         
Sub-Investigator: Milena Di Leo, MD         
Sub-Investigator: Roberta Maselli, MD         
Sub-Investigator: Alessandro Fugazza, MD         
Sub-Investigator: Alessia Galtieri, MD         
Sub-Investigator: Elisa Ferrara, MD         
Sub-Investigator: Gaia Pellegatta, MD         
Sponsors and Collaborators
Istituto Clinico Humanitas

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Responsible Party: Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT03987828    
Other Study ID Numbers: Non_curativeESD
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms