No registrations found.
ID
Source
Brief title
Health condition
late effects of Hodgkin lymphoma treatment
colorectal neoplasia
Sponsors and support
MLDS
Intervention
Outcome measures
Primary outcome
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 outcome
- 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
Background summary
Hodgkin lymphoma survivors have an increased risk of developing colorectal cancer. Currently, there is no surveillance program for colorectal cancer in Hodgkin lymphoma survivors and the potential value of different surveillance methods in this population is unknown.
The first objective of this study is to assess the value of colonoscopy screening in HL survivors. The second objectives are to evaluate the neoplasia characteristics and its relation to radiotherapy and chemotherapy, in order to improve the understanding of the carcinogenesis of colorectal neoplasia after the exposure to radiotherapy and / or chemotherapy, to evaluate the cost-effectiveness and to evaluate the burden of colonoscopy. Finally, the effectiveness of a stool test for screening will be evaluated using the colonoscopy as a reference value.
Study objective
Because of the high colorectal cancer (CRC) risk, Hodgkin lymphoma (HL) survivors should be offered colonoscopy screening, which has the potential to reduce CRC incidence and mortality. However, the diagnostic yield, cost-effectiveness and burden of colonoscopy in HL survivors have not been assessed. The molecular profile of radiotherapy- or chemotherapy-associated colorectal neoplasia is also unknown.
Study design
-
Intervention
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 be asked to fill out two questionnaires and to provide one stool sample for a fecal immunochemical test and a molecular test.
Participation in this study provides no individual benefit for the patient.
M.E. Leerdam, van
Amsterdam
The Netherlands
020-5122566
m.v.leerdam@nki.nl
M.E. Leerdam, van
Amsterdam
The Netherlands
020-5122566
m.v.leerdam@nki.nl
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
-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% of control; partial thromboplastin 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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4837 |
| NTR-old | NTR4961 |
| CCMO | NL.48096.031.14 |