late effects of Hodgkin lymphoma treatment colorectal neoplasia
Conditions
Interventions
The high risk of CRC is an indication for colonoscopy screening in HL survivors. Participation in the study includes the minimal additional risk of six to eight normal tissue biopsies. Patients will b
Sponsors
NKI-AVL
Eligibility
Inclusion criteria
Inclusion criteria: -HL diagnosis at the age of 16-50 years -Treatment for HL between 1965 and 2007 -Treatment of primary or recurrent HL consisting of infradiaphragmatic radiotherapy and chemotherapy (any regimen) or chemotherapy containing a cumulative procarbazine dose of ≥2.8 g/m2 (e.g. ≥2 MOPP, ≥4 BEACOPP or ≥4 MOPP/ABV courses) -Survival of at least 8 years after the first treatment that included infradiaphragmatic radiotherapy and chemotherapy or procarbazine-containing chemotherapy -Age of 25 years or older -Life expectancy of five years or more Inclusion NEW: 4-apr-2016 -HL diagnosis at the age of 16-50 years -Treatment for HL between 1965 and 2007 -Treatment of primary or recurrent HL consisting of infradiaphragmatic radiotherapy (any fields) and chemotherapy (any regimen) and/or infradiaphragmatic radiotherapy consisting of at least para-aortic and iliac fields and/or chemotherapy containing a cumulative procarbazine dose of ≥2.8 g/m2 (e.g. ≥2 MOPP, ≥4 BEACOPP or ≥4 MOPP/ABV courses) -Survival of at least 8 years after this treatment -Age of 25 years or older -Life expectancy of five years or more
Exclusion criteria
Exclusion criteria: -Proctocolectomy -Colonoscopy surveillance for other indications (including hereditary CRC syndrome, familial CRC syndrome, inflammatory bowel disease, history of colorectal adenoma or CRC) -Colonoscopy in the past five years -On-going cytotoxic treatment or radiotherapy for malignant disease -Coagulopathy (prothrombin time 50 seconds) or anticoagulants (marcoumar, acenocoumarol or new oral anticoagulants) that cannot be stopped -Comorbidity leading to an impaired physical performance (World health organization (WHO) performance status 3-4) or mental retardation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The diagnostic yield of advanced colorectal neoplasia detection by a first screening colonoscopy. Advanced colorectal neoplasia is defined as an adenoma with high grade dysplasia, >25% villous component or more than 10 mm diameter or CRC. | — |
Secondary
| Measure | Time frame |
|---|---|
| - the molecular profile of colorectal neoplasia in HL survivors - the relation of colorectal neoplasia characteristics (anatomic distribution, histology, molecular changes) with radiotherapy and chemotherapy - the cost-effectiveness of screening colonoscopy in HL survivors - the burden of screening colonoscopy in HL survivors - the performance of the fecal immunochemical test (FIT) and a molecular stool test using the colonoscopy as a reference value - the development colonoscopy surveillance recommendations for HL survivors | — |
Contacts
Public ContactM.E. Leerdam, van
Plesmanlaan 121, 1066 CX, Amsterdam
Outcome results
None listed