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Noncurative Endoscopic Resection of Colorectal Adenocarcinoma (NoncurativeESD)
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 |
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 Type : | Observational |
| Actual 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 : | September 1, 2019 |
| Actual Primary Completion Date : | December 31, 2020 |
| Actual Study Completion Date : | December 31, 2020 |
- Survival [ Time Frame: 6 Months ]Overall survival cancer-specific survival and disease-free survival rate after noncurative ESD.
| 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 |
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.
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.
| Italy | |
| Endoscopy Unit, Humanitas Research Hospital | |
| Rozzano, Milano, Italy, 20089 | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | June 11, 2019 | ||||
| First Posted Date | June 17, 2019 | ||||
| Last Update Posted Date | March 18, 2021 | ||||
| Actual Study Start Date | September 1, 2019 | ||||
| Actual Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Survival [ Time Frame: 6 Months ] Overall survival cancer-specific survival and disease-free survival rate after noncurative ESD.
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| 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. |
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| 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 | ||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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| 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. |
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| Condition | Noncurative Resection | ||||
| Intervention | Not Provided | ||||
| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
500 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Actual Study Completion Date | December 31, 2020 | ||||
| Actual Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria: - undergoing non-curative colorectal endoscopic submucosal dissection (ESD). Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Italy | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03987828 | ||||
| Other Study ID Numbers | Non_curativeESD | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| 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 | March 2021 | ||||
