colon cancer MedDRA version: 14.1 Level: PT Classification code 10009944 Term: Colon cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: MAASOL
Pharmaceutical Form: Powder for suspension for injection
INN or Proposed INN: HUMAN ALBUMIN AS MACROAGGREGATES
Concentration unit: mg milligram(s)
Concentration type: equal
Concentr
Sponsors
ISTITUTO EUROPEO DI ONCOLOGIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Aged = 18 years - Able to provide written informed consent - Diagnosis of early (T1) colon cancer or of endoscopically removed colonic polyp, with malignant histology (infiltration of the submucosa) and requiring surgical radicalization - Colon cancer suitable for resection by minimally invasive surgery - Patient fit for robotic-assisted or standard laparoscopic colon resection - American Society of Anesthesiologists (ASA) physical status =3 Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 17 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 17
Exclusion criteria
Exclusion criteria: Benign lesions of the colon or of the rectum above 12 cm from the anal verge - Benign or malignant diseases of the anal canal - Synchronous colorectal tumours requiring multi-segment surgical resection - Co-existent inflammatory bowel disease - Clinical or radiological evidence of metastatic spread - Concurrent or previous diagnosis of invasive cancer within 5 years that could confuse diagnosis (non-melanomatous skin cancer or superficial bladder cancer treated with curative intent are acceptable) - History of psychiatric or addictive disorder or other medical condition that, in the opinion of the investigator, would preclude the patient from meeting the trial requirements - Pregnancy - Breast feeding - Participation in another colon cancer clinical trial relating to lesion mapping techniques
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Secondary objective is validation of ROLL technique to identify sentinel lymphnodes.;Primary end point(s): occurrence of positive radioguided identification of the primary tumour site or of the scar of endoscopic polypectomy;Timepoint(s) of evaluation of this end point: the evaluation is performed at the time of surgery and after the histopathologic examination.;Main Objective: The main objective of this study is the evaluation of the feasibility and efficacy of ROLL to localize early colon cancers or scars of endoscopic polypectomies before minimally-invasive colon resections. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): identification of sentinel lymphonodes;Timepoint(s) of evaluation of this end point: after the histopathologic examination | — |
Countries
Italy
Contacts
Public ContactUfficio studi clinici
Istituto Europeo Oncologia
Outcome results
None listed