Primary objective of this multicenter study is to assess the diagnostic yield of colonoscopy surveillance in testicular cancer (TC) survivors treated with platinum-based chemotherapy (cisplatin). Furthermore, we will evaluate the molecular profile…
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
To determine the diagnostic yield of advanced colorectal neoplasia by screening
colonoscopy in TC survivors treated with platinum-based chemotherapy
Secondary outcome
- To determine whether the molecular profile of colorectal neoplasia in TC
survivors treated with platinum-based chemotherapy differs from sporadic
colorectal neoplasia
- To examine whether we can detect platinum in plasma and if so to examine
whether platinum levels are associated with the outcome of advanced colorectal
lesions and cumulative cisplatin dose
- To develop colonoscopy surveillance screening recommendations for TC
survivors treated with platinum-based chemotherapy
- To evaluate the burden of screening colonoscopy in TC survivors treated with
platinum-based chemotherapy
- To evaluate the cost-effectiveness of colonoscopy in TC survivors treated
with platinum-based chemotherapy
- To evaluate the sensitivity and specificity of stool tests for detecting
advanced colorectal neoplasia in TC survivors treated with platinum-based
chemotherapy
Background summary
Testicular cancer (TC) survivors have an increased risk of various second
primary malignancies. A recent cohort study showed that platinum-based
chemotherapy was associated with increased risk of colorectal cancer (CRC) in a
dose dependent manner (hazard ratio (HR) 3.85 for platinum-containing
chemotherapy versus no platinum-containing chemotherapy, 95% confidence
interval 1.67-8.92). An increased risk of secondary gastrointestinal
malignancies also has been previously described in childhood cancer survivors
treated with platinum-based chemotherapy with a relative risk of 7.6. Recently,
colonoscopy surveillance has also been recommended in Hodgkin lymphoma
survivors treated with abdominal radiotherapy and/or procarbazine.
Currently, it is unknown whether CRC that develop in TC survivors exposed to
cisplatin are histopathologically or molecularly different from sporadic CRC.
If present, such differences might be related to the previous cisplatin
treatment.The aim of this multicentre prospective study is to assess the
diagnostic yield of colonoscopy surveillance in TC survivors treated with
platinum-based chemotherapy, mainly cisplatin. We will evaluate whether these
patients will benefit from surveillance. We will compare screening yields with
that a control group of the NordICC study including average individuals who
underwent a first screening colonoscopy. Also the molecular profile of advanced
neoplasia will be assessed to detect possible differences with sporadic
neoplasia, which will hopefully contribute to more personalized CRC treatment.
Additionally, we will determine the level of platinum in both the plasma and
colorectal tissue to evaluate a possible correlation with the development of
advanced neoplastic colorectal lesions and/or CRC. Furthermore, we will
evaluate the burden and cost-effectiveness of colonoscopy and assess the
effectiveness of stool tests for CRC screening in TC survivors compared to
standard colonoscopy.
Study objective
Primary objective of this multicenter study is to assess the diagnostic yield
of colonoscopy surveillance in testicular cancer (TC) survivors treated with
platinum-based chemotherapy (cisplatin). Furthermore, we will evaluate the
molecular profile of advanced colorectal neoplasia, effectiveness of stool
tests, platinum in plasma, burden and cost-effectiveness of colonoscopy.
Study design
A prospectively cross-sectional screening study in multicenter setting.
Study burden and risks
Participation of patients in this study can be considered as standard care due
to the fact that these patients should be offered colonoscopy surveillance as
they can be considered a high-risk population for developing CRC. Patients will
visit the hospital at least two times (once for an intake and once to undergo a
colonoscopy). Depending on the outcome of the colonoscopy patients will receive
a telephone consultation or an appointment at the outpatient clinic.
Participants are asked for one blood sample when they visit the hospital for
either intake or colonoscopy (6 ml EDTA containing tube). Patients will be
asked to fill out two questionnaires before and after colonoscopy and to
provide a stool sample for fecal testing before the start of the bowel
preparation. Participation in this study provides a first screening colonoscopy
with the potential to detect and resect colorectal neoplasia. Six to eigth
additional biopsies of normal colorectal tissue will be taken with minimal
additional risk.
Plesmanlaan 121
Amsterdam 1066 CX
NL
Plesmanlaan 121
Amsterdam 1066 CX
NL
Listed location countries
Age
Inclusion criteria
- Diagnosis of TC before age of 50 years
- Treatment of primary TC consisting at least three cycles of platinum-based
chemotherapy consisting of cisplatin
- At least 8 years after initial treatment
- At least 35 years of age and not older than 75 years
- Detection and potential treatment of advanced colorectal neoplasia is
considered useful
Exclusion criteria
- A history of a proctocolectomy
- Colonoscopy surveillance for other indications (including hereditary CRC
syndrome, familial CRC syndrome, inflammatory bowel disease, history of
colorectal adenoma or CRC). Result of the prior colonoscopy will be put in the
database and used for additional analyses
- Having received a colonoscopy in the past three years (however the result of
the prior colonoscopy will be put in the database and used for additional
analyses )
- Currently receiving cytotoxic treatment or radiotherapy for malignant disease
- Coagulopathy (prothrombin time <50% of control; partial tromboplastin time
>50 seconds) or anticoagulants (fenprocoumon, acenocoumarol, platelet
aggregation inhibitors or new oral anticoagulants) that cannot be stopped or
savely bridged
- Comorbidity leading to an impaired physical performance (World health
organization (WHO) performance status 3-4) or mental retardation
- Limited Dutch language skills
- 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 | NL68513.031.19 |