Testicular CancerCATCHERNCT04180033
Diagnostic Yield of Colonoscopy Surveillance in Testicular Cancer Survivors Treated With Platinum-based Chemotherapy
A study testing Colonoscopy surveillance in people with Testicular Cancer and Colorectal Neoplasms, run by The Netherlands Cancer Institute at 4 sites in Netherlands.
Trial summary
Testicular cancer (TC) survivors treated with platinum-based chemotherapy have an increased risk of colorectal cancer (CRC) (hazard ratio (HR) 3.9 for platinum-containing chemotherapy versus no platinum-containing chemotherapy, 95% confidence interval 1.7-8.9). Read more about this study
- Who is it for?
- Ages 35 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Testicular Cancer, Colorectal Neoplasms
- What is being tested?
- Colonoscopy surveillance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 4 sitesNetherlands
- Study dates
- 18 Feb 2020to 25 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 70 75 years
- Detection and potential treatment of advanced colorectal neoplasia is considered beneficial
Who cannot join
- 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
- 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 safely bridged if necessary
- 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
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites
Antoni van Leeuwenhoek Hospital
Amsterdam, 1066CX
Radboud University Medical Center
Nijmegen, Gelderland, 6500 HB
Erasmus Medical Center
Rotterdam, South Holland, 3000 CA
University Medical Center Utrecht
Utrecht, 3584 CX
About this study
Testicular cancer (TC) survivors treated with platinum-based chemotherapy have an increased risk of colorectal cancer (CRC) (hazard ratio (HR) 3.9 for platinum-containing chemotherapy versus no platinum-containing chemotherapy, 95% confidence interval 1.7-8.9). Colonoscopy screening can reduce CRC incidence and mortality. Given this increased risk of CRC, colonoscopy surveillance should be considered for TC survivors treated with platinum-based chemotherapy.
The aim of this study is to evaluate the diagnostic yield of advanced colorectal neoplasia during colonoscopy surveillance in TC survivors treated with platinum-based chemotherapy. The secondary objectives are to determine cost-effectiveness and burden of colonoscopy. Furthermore, the molecular profile of advanced neoplasia will be evaluated to create insight into the carcinogenesis. The effectiveness of fecal immunochemical testing (FIT) will be evaluated with colonoscopy as a reference. Finally, blood plasma platinum-levels will be determined to examine a potential correlation with the outcome of the ccolonoscopy.
Read the detailed description
Rationale: 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) 3.9 for platinum-containing chemotherapy versus no platinum-containing chemotherapy, 95% confidence interval 1.7-8.9). Colonoscopy screening can reduce CRC incidence and mortality. Given this increased risk of CRC, colonoscopy surveillance should be considered for TC survivors treated with platinum-based chemotherapy. However, the diagnostic yield, cost-effectiveness and burden of colonoscopy in TC survivors treated with platinum-based chemotherapy has never been assessed. Additionally, the molecular profile of advanced neoplastic lesions and CRC in TC survivors treated with platinum-based chemotherapy has not been established but can provide valuable insight into CRC carcinogenesis in this group of patients. Also the effectiveness of fecal tests has not been evaluated among TC survivors treated with platinum-based chemotherapy compared to that among population controls.
Objective: The primary objective of this study is to assess the diagnostic yield of colonoscopy surveillance in TC survivors treated with platinum-based chemotherapy. The secondary objectives are 1) to evaluate the molecular characteristics of colorectal (advanced) neoplasia in TC patients in relation to the cumulative doses of/ level of plasma cisplatin, in order to improve the understanding of CRC carcinogenesis following cisplatin exposure, 2) to determine the association of platinum levels in plasma with cumulative administered cisplatin doses as well as with presence of colorectal (advanced) neoplasia at colonoscopy and to determine the platinum amount in the colorectal tissue derived during primary colonoscopy screening, 3) to evaluate the cost-effectiveness and burden of colonoscopy. Our 4th secondary objective is to assess the effectiveness of a stool test for CRC screening in TC survivors compared to standard colonoscopy.
Study design: A multicentre prospective cross-sectional screening study.
Study population: TC survivors will be derived from an established, well-defined multicentre cohort. Inclusion criteria of this study are 1) participants should have been treated for TC in a participating Dutch hospital before the age of 50 years, 2) treatment consisted of at least three cycles of platinum-based chemotherapy (cisplatin) with or without additional radiotherapy, 3) participants should be at least 8 years after start of treatment, with a minimum age at first colonoscopy screening of 35 years, 4) the maximum age at participation is 75 years, 5) detection and potential treatment of advanced colorectal neoplasia is considered beneficial.
- Conditions
- Testicular Cancer, Colorectal Neoplasms
- Being tested
- Colonoscopy surveillance
- Keywords
- Colonoscopy surveillance
- Medical subject headings
- Testicular Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colonoscopy surveillanceDiagnostic test
Also called Fecal immunochemical test (FIT)
Participants will be asked to undergo a first colonoscopy surveillance.
| Study group | Role | What they receive |
|---|---|---|
| Colonoscopy surveillance in TC survivors | Other | TC survivors treated with platinum-based chemotherapy will be invited to undergo a colonoscopy surveillance. Receives: Diagnostic Test: Colonoscopy surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield advanced colorectal neoplasia
Diagnostic yield of advanced colorectal neoplasia detection by a first colonoscopy surveillance.
Measured: 2 years
Secondary outcomes (8)
Features of colorectal neoplasia as classified during colonoscopy
Colorectal neoplasia characteristics including endoscopic features (morphology, prevalence, size and location)
Measured: 2 years
Molecular features of colorectal neoplasia and normal mucosa as evaluated histopathologically, molecular and by immunohistochemistry
The molecular profile of advanced colorectal neoplasia and normal colorectal tissue will be evaluated by immunohistochemistry and molecular pathology
Measured: 6 months
Platinum levels in plasma
Measure platinum in plasma and possibly in FFPE material of CRC
Measured: 2 years
Fecal immunochemical test (FIT)
Performance (sensitivity/specificity/positive predictive value/negative predictive value) of the fecal immunochemical test (FIT) stool test to detect advanced colorectal neoplasia will be evaluated using the colonoscopy as reference standard.
Measured: 2 years
Determination of the most cost-effectiveness strategy for colonoscopy surveillance by using the MISCAN model
Cost-effectiveness analysis of colonoscopy screening using the microsimulation screening analysis (MISCAN) model to evaluate the most cost-effective strategy.
Measured: 3 months
Quality of life of participant before and after colonoscopy
Quality of life before and after colonoscopy will be evaluated by validated questionnaires (EQ-5D). This is a standardized instrument to evaluate five health categories (mobility, self care, daily activities, pain/discomfort and fear/depression). The items can be scored in three values; no/some/a lot of problems. A higher score represents a worse outcome.
Furthermore, the health will be scored on a 0 to 100 scale. A higher score will correspond with a better health interpreted health of the participant.
Measured: 2 years
Worries about cancer
The cancer worry scale will be used to evaluate the worries about cancer (4 point scale; 1 (hardly never) to 4 (regularly() via a questionnaire before colonoscopy
Measured: 2 years
Burden of colonoscopy
Two questionnaire (before and after colonoscopy) will be performed to evaluate the expected and experienced burden of colonoscopy using a 5-point scale (1 - Hardly to 5 - Very)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start18 Feb 2020
- Primary completion25 Nov 2022
- Study completion25 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Testicular CancerStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will be invited to undergo a colonoscopy surveillance.
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Monique van Leerdam, MD PhD, Principal investigator, Antoni van Leeuwenhoek Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04180033
- Sponsor's protocol ID
- M19CTR
- Acronym
- CATCHER
- Status last verified
- Feb 2020
- First submitted
- 6 Nov 2019
- Last updated
- 31 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Breekveldt ECH, Ykema BLM, Huitema ADR, Gietema JA, Beijnen JH, Snaebjornsson P, Schaapveld M, van Leeuwen FE, Rosing H, van Leerdam ME; CATCHER study working group. Platinum retention in plasma, urine, and normal colonic mucosa in cisplatin-treated testicular cancer survivors. PLoS One. 2024 Nov 14;19(11):e0312994. doi: 10.1371/journal.pone.0312994. eCollection 2024.
PubMed 39541403Ykema BLM, Bisseling TM, Spaander MCW, Moons LMG, van der Biessen-van Beek D, Saveur L, Kerst M, Mulder SF, de Wit R, Zweers D, Meijer GA, Beijnen JH, Lansdorp-Vogelaar I, van Leeuwen FE, Snaebjornsson P, van Leerdam ME. Diagnostic yield of colonoscopy surveillance in testicular cancer survivors treated with platinum-based chemotherapy: study protocol of a prospective cross-sectional cohort study. BMC Gastroenterol. 2021 Feb 12;21(1):67. doi: 10.1186/s12876-021-01639-2.
PubMed 33579196
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Yield of Colonoscopy Surveillance in Testicular Cancer Survivors Treated With Platinum-based Chemotherapy
- ClinicalTrials.gov ID
- NCT04180033
- Acronym / sponsor ID
- CATCHER / M19CTR
- Conditions
- Testicular Cancer, Colorectal Neoplasms
- Keywords
- Colonoscopy surveillance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- 18 Feb 2020 (actual)
- Primary completion
- 25 Nov 2022 (actual)
- Study completion
- 25 Nov 2022 (actual)
- First posted
- 27 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Testicular cancer (TC) survivors treated with platinum-based chemotherapy have an increased risk of colorectal cancer (CRC) (hazard ratio (HR) 3.9 for platinum-containing chemotherapy versus no platinum-containing chemotherapy, 95% confidence interval 1.7-8.9). Colonoscopy screening can reduce CRC incidence and mortality. Given this increased risk of CRC, colonoscopy surveillance should be considered for TC survivors treated with platinum-based chemotherapy.
The aim of this study is to evaluate the diagnostic yield of advanced colorectal neoplasia during colonoscopy surveillance in TC survivors treated with platinum-based chemotherapy. The secondary objectives are to determine cost-effectiveness and burden of colonoscopy. Furthermore, the molecular profile of advanced neoplasia will be evaluated to create insight into the carcinogenesis. The effectiveness of fecal immunochemical testing (FIT) will be evaluated with colonoscopy as a reference. Finally, blood plasma platinum-levels will be determined to examine a potential correlation with the outcome of the ccolonoscopy.
Detailed description
Rationale: 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) 3.9 for platinum-containing chemotherapy versus no platinum-containing chemotherapy, 95% confidence interval 1.7-8.9). Colonoscopy screening can reduce CRC incidence and mortality. Given this increased risk of CRC, colonoscopy surveillance should be considered for TC survivors treated with platinum-based chemotherapy. However, the diagnostic yield, cost-effectiveness and burden of colonoscopy in TC survivors treated with platinum-based chemotherapy has never been assessed. Additionally, the molecular profile of advanced neoplastic lesions and CRC in TC survivors treated with platinum-based chemotherapy has not been established but can provide valuable insight into CRC carcinogenesis in this group of patients. Also the effectiveness of fecal tests has not been evaluated among TC survivors treated with platinum-based chemotherapy compared to that among population controls.
Objective: The primary objective of this study is to assess the diagnostic yield of colonoscopy surveillance in TC survivors treated with platinum-based chemotherapy. The secondary objectives are 1) to evaluate the molecular characteristics of colorectal (advanced) neoplasia in TC patients in relation to the cumulative doses of/ level of plasma cisplatin, in order to improve the understanding of CRC carcinogenesis following cisplatin exposure, 2) to determine the association of platinum levels in plasma with cumulative administered cisplatin doses as well as with presence of colorectal (advanced) neoplasia at colonoscopy and to determine the platinum amount in the colorectal tissue derived during primary colonoscopy screening, 3) to evaluate the cost-effectiveness and burden of colonoscopy. Our 4th secondary objective is to assess the effectiveness of a stool test for CRC screening in TC survivors compared to standard colonoscopy.
Study design: A multicentre prospective cross-sectional screening study.
Study population: TC survivors will be derived from an established, well-defined multicentre cohort. Inclusion criteria of this study are 1) participants should have been treated for TC in a participating Dutch hospital before the age of 50 years, 2) treatment consisted of at least three cycles of platinum-based chemotherapy (cisplatin) with or without additional radiotherapy, 3) participants should be at least 8 years after start of treatment, with a minimum age at first colonoscopy screening of 35 years, 4) the maximum age at participation is 75 years, 5) detection and potential treatment of advanced colorectal neoplasia is considered beneficial.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will be invited to undergo a colonoscopy surveillance.
| Arm | Type | Receives |
|---|---|---|
| Colonoscopy surveillance in TC survivors | Other | Diagnostic Test: Colonoscopy surveillanceTC survivors treated with platinum-based chemotherapy will be invited to undergo a colonoscopy surveillance. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 70 75 years
- Detection and potential treatment of advanced colorectal neoplasia is considered beneficial
Key exclusion criteria (8 listed)
- 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
- 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 safely bridged if necessary
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colonoscopy surveillanceAlso: Fecal immunochemical test (FIT)Participants will be asked to undergo a first colonoscopy surveillance. | Diagnostic test | Colonoscopy surveillance in TC survivors |
Primary outcome
Diagnostic yield advanced colorectal neoplasia
Time frame: 2 years
Diagnostic yield of advanced colorectal neoplasia detection by a first colonoscopy surveillance.
8 secondary outcomes
Features of colorectal neoplasia as classified during colonoscopy
Time frame: 2 years
Molecular features of colorectal neoplasia and normal mucosa as evaluated histopathologically, molecular and by immunohistochemistry
Time frame: 6 months
Platinum levels in plasma
Time frame: 2 years
Fecal immunochemical test (FIT)
Time frame: 2 years
Determination of the most cost-effectiveness strategy for colonoscopy surveillance by using the MISCAN model
Time frame: 3 months
Quality of life of participant before and after colonoscopy
Time frame: 2 years
Worries about cancer
Time frame: 2 years
Burden of colonoscopy
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Derived from this study: PubMed 39541403Breekveldt ECH, Ykema BLM, Huitema ADR, Gietema JA, Beijnen JH, Snaebjornsson P, Schaapveld M, van Leeuwen FE, Rosing H, van Leerdam ME; CATCHER study working group. Platinum retention in plasma, urine, and normal colonic mucosa in cisplatin-treated testicular cancer survivors. PLoS One. 2024 Nov 14;19(11):e0312994. doi: 10.1371/journal.pone.0312994. eCollection 2024.
- Derived from this study: PubMed 33579196Ykema BLM, Bisseling TM, Spaander MCW, Moons LMG, van der Biessen-van Beek D, Saveur L, Kerst M, Mulder SF, de Wit R, Zweers D, Meijer GA, Beijnen JH, Lansdorp-Vogelaar I, van Leeuwen FE, Snaebjornsson P, van Leerdam ME. Diagnostic yield of colonoscopy surveillance in testicular cancer survivors treated with platinum-based chemotherapy: study protocol of a prospective cross-sectional cohort study. BMC Gastroenterol. 2021 Feb 12;21(1):67. doi: 10.1186/s12876-021-01639-2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monique van Leerdam, MD PhD principal investigator
Antoni van Leeuwenhoek Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colonoscopy surveillance in people with Testicular Cancer and Colorectal Neoplasms, run by The Netherlands Cancer Institute at 4 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield advanced colorectal neoplasia (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04180033, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.