The first objective 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…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Diagnostic yield of advanced colorectal neoplasia detected by a colonoscopy
Secondary outcome
- Molecular characteristics of advanced colorectal neoplasia
- The relation of neoplasia characteristics to radiotherapy and / or
chemotherapy
- The cost-effectiveness of colonoscopy screening
- The burden of colonoscopy screening
- Performance of fecal immunochemical test and molecular stool test
- The development of CRC surveillance guidelines for HL survivors
Background summary
Second primary malignancies are a major cause of morbidity and mortality in
Hodgkin lymphoma (HL) survivors. A recent retrospective analysis showed an
increased incidence of colorectal cancer (CRC) in long-term survivors of HL
compared with the general population (standardized incidence ratio (SIR) of 2.7
(95% confidence interval (CI) 2.0-3.6). HL survivors who were treated with high
dose (>4.2 g/m2) procarbazine or infradiaphragmatic radiotherapy in combination
with chemotherapy have an even higher risk (SIR 4.7 (95% CI 2.7-7.6) and 5.6
(95% CI 3.5-8.4), resp.).
Radiotherapy- or chemotherapy-associated CRC may be a distinct subgroup with a
different etiology and prognosis and may require a different clinical approach.
Because of the high CRC risk, HL survivors should be offered colonoscopy
screening, which reduces 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 objective
The first objective 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 design
A prospective cohort study in a multicenter setting.
Study burden and risks
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.
Plesmanlaan 121
Amsterdam 1066CX
NL
Plesmanlaan 121
Amsterdam 1066CX
NL
Listed location countries
Age
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
o infradiaphragmatic radiotherapy (any field(s)) and chemotherapy (any regimen)
and/or
o infradiaphragmatic radiotherapy consisting of at least para-aortal and iliac fields
and/or
o 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
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
• No informed consent
Design
Recruitment
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 |
|---|---|
| CCMO | NL48096.031.14 |