Cancer-associated ThrombosisONCOTHROMBNCT03114618
A New Clinic-Genetic Risk Score for Predicting Venous Thromboembolic Events in Cancer Patient
An observational study of Cancer-associated Thrombosis and Genetic Predisposition, run by Andres muñoz at 9 sites in Spain.
Trial summary
Venous thromboembolism (VTE) is a common disease in cancer patients and one of the major causes of cancer-associated mortality. Risk for developing VTE increases when cancer patients are receiving chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cancer-associated Thrombosis, Genetic Predisposition
- How many people
- 416 participants
- Where
- 9 sitesSpain
- Study dates
- Mar 2013to Feb 2021
- Phase
- Observational
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will include patients diagnosed with colorectal, esophago-gastric, biliary tract, pancreas or lung cancer who have not previously been treated with chemotherapy or chemotherapy and radiation therapy and are candidate for chemotherapy in outpatient setting
Who may be able to join
- Patients over 18 years of age.
- Patients treated in outpatient clinics with a documented histological or cytological diagnosis for non-microcytic lung, colorectal, biliary tract cancer, pancreatic or esophago-gastric cancer at an advanced stage, locally advanced or localized not previously treated with systemic chemotherapy and/or radiation therapy who are candidate for chemotherapy in outpatient setting.
- Performance status 0-2.
- Patients signing the study informed consent form.
Who cannot join
- Life expectancy of less than 3 months.
- Patients undergoing anti-coagulant treatment before the cancer diagnosis for reasons other than a concurrent venous thromboembolic event.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Spain9 sites
Complejo Hospitalario Torrecárdenas
Almería, Almería
Hospital Clinic
Barcelona
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid
Hospital Virgen de las Nieves
Granada
Hospital General Universitario Gregorio Marañón
Madrid
Hospital Universitario la Paz
Madrid
Hospital Universitario Ramón y Cajal
Madrid
Complejo Hospitalario de Orense
Ourense
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria
About this study
Official title: Genomic Predictors Indicating the Risk of Venous Thromboembolic Disease in Cancer Patients Treated in Outpatient Clinics
Venous thromboembolism (VTE) is a common disease in cancer patients and one of the major causes of cancer-associated mortality. Risk for developing VTE increases when cancer patients are receiving chemotherapy. Current risk scores for predicting cancer-associated VTE in ambulatory patients had low/moderate discrimination and clinical sensitivity. These models use clinical and biochemical parameters of the patient.
In the development of VTE genetics play a relevant role. The product Thrombo inCode (TiC) assess VTE risk prediction by using a combination of a genetic risk score (GRS) and clinical parameters from the patient. The investigators hypothesized that the GRS included in TiC combined with clinical parameter some of them associated with cancer could be better predicted by TiC than by current risk scores (Khorana score).
After publishing the primary results in 2018, we have expanded the GRS in a external validation cohort adding gliomas and biliary tract tumors. Also we have incorporated the assessment of D-dimer in order to improve the predictive capability.
Read the detailed description
The working hypothesis of this study establishes that the risk of cancer patients suffering a thromboembolic event is conditioned by individual genomic factors. The genes to be analyzed have clearly demonstrated their relationship with thromboembolic disease in other clinical contexts. This study is considered the initiation of a field of research in genomic risk markers indicating a risk of thrombosis in cancer patients. The ultimate goal of the study is to establish a clinic-genomic score for selecting patients with a high risk of suffering thrombotic events who can benefit from guided thromboprophylaxis. Its secondary goal is to prevent the adverse effects of ineffective therapies in other patients (low-risk patients not requiring an anti-thrombotic prophylaxis).
The aim is to demonstrate the link between the clinic-genetic profile and the risk of suffering thromboembolic events in the group of cancer patients. The working hypothesis establishes that cancer patients who develop thrombotic events will have a higher score for the thrombosis risk clinic-genetic profile than cancer patients not developing thromboembolic events. The second aim is to analyze whether the thrombosis clinic-genetic risk score improves the detection of patients at risk of suffering a thromboembolic event compared to the Khorana predictive model routinely used (Khorana score).
Current validations ongoing:
An external retrospective validation adding 250 patients more and including D-dimer and other types of high-risk neoplasm.
An external prospective validation (second ONCOTRHROMB12-01 cohort 2) adding 450 patients more and including D-dimer and other types of high-risk neoplasm.
- Keywords
- Venous thrombosis, Cancer, Risk Model Assessment, Genomic
- Medical subject headings
- Genetic Predisposition to Disease, Venous Thrombosis, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous thromboembolism events
The development of venous thromboembolism will be registered
Measured: During the 18 months of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study startMar 2013
- Primary completionDec 2020
- Study completionFeb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cancer-associated ThrombosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andres muñoz
- Sponsor type
- University, hospital or other
- Collaborators
- Servicio de Oncología Médica. HGU Gregorio Marañón. Madrid, Unitat de Genòmica de Malalties Complexes. Institut d'Investigació Sant Pau, Hospital Universitario La Paz, Hospital Universitario Ramon y Cajal, Hospital Clinic of Barcelona, Hospital Universitario de Fuenlabrada, Hospital Universitario Marqués de Valdecilla, Complexo Hospitalario de Ourense, Complejo Universitario Torrecárdenas, Almería, Gendiag, Ferrer inCode, S.L., Unitat d'Hemostasia i Trombosi. Hospital de la Santa Creu i Sant Pau, LEO Pharma, Sociedad Española de Trombosis y Hemostasia (SETH), Sociedad Española de Oncología Médica (SEOM), University Hospital Virgen de las Nieves, Hospital Obispo Polanco, Complejo Hospitalario Universitario de Vigo, Hospital General Universitario Elche, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz, Hospital General de Ciudad Real
- Responsible party
- Sponsor-investigator, Andres muñoz, Hospital General Universitario Gregorio Marañon
- Investigators
- Andrés J. Muñoz Martín, MD PhD, Principal investigator, Hospital General Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03114618
- Sponsor's protocol ID
- ONCOTHROMB12-01
- Acronym
- ONCOTHROMB
- Status last verified
- Apr 2022
- First submitted
- 14 Mar 2017
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Soria JM, Morange PE, Vila J, Souto JC, Moyano M, Tregouet DA, Mateo J, Saut N, Salas E, Elosua R. Multilocus genetic risk scores for venous thromboembolism risk assessment. J Am Heart Assoc. 2014 Oct 23;3(5):e001060. doi: 10.1161/JAHA.114.001060.
PubMed 25341889Rubio-Terres C, Soria JM, Morange PE, Souto JC, Suchon P, Mateo J, Saut N, Rubio-Rodriguez D, Sala J, Gracia A, Pich S, Salas E. Economic analysis of thrombo inCode, a clinical-genetic function for assessing the risk of venous thromboembolism. Appl Health Econ Health Policy. 2015 Apr;13(2):233-42. doi: 10.1007/s40258-015-0153-x.
PubMed 25652150Munoz Martin AJ, Ortega I, Font C, Pachon V, Castellon V, Martinez-Marin V, Salgado M, Martinez E, Calzas J, Ruperez A, Souto JC, Martin M, Salas E, Soria JM. Multivariable clinical-genetic risk model for predicting venous thromboembolic events in patients with cancer. Br J Cancer. 2018 Apr;118(8):1056-1061. doi: 10.1038/s41416-018-0027-8. Epub 2018 Mar 28.
PubMed 29588512Munoz A, Ay C, Grilz E, Lopez S, Font C, Pachon V, Castellon V, Martinez-Marin V, Salgado M, Martinez E, Calzas J, Ortega L, Ruperez A, Salas E, Pabinger I, Soria JM. A Clinical-Genetic Risk Score for Predicting Cancer-Associated Venous Thromboembolism: A Development and Validation Study Involving Two Independent Prospective Cohorts. J Clin Oncol. 2023 Jun 1;41(16):2911-2925. doi: 10.1200/JCO.22.00255. Epub 2023 Feb 2.
PubMed 36730884
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genomic Predictors Indicating the Risk of Venous Thromboembolic Disease in Cancer Patients Treated in Outpatient Clinics
- ClinicalTrials.gov ID
- NCT03114618
- Acronym / sponsor ID
- ONCOTHROMB / ONCOTHROMB12-01
- Keywords
- Venous thrombosis, Cancer, Risk Model Assessment, Genomic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- Andres muñozUniversity, hospital or other
- Collaborators
- Servicio de Oncología Médica. HGU Gregorio Marañón. Madrid, Unitat de Genòmica de Malalties Complexes. Institut d'Investigació Sant Pau, Hospital Universitario La Paz, Hospital Universitario Ramon y Cajal, Hospital Clinic of Barcelona, Hospital Universitario de Fuenlabrada, Hospital Universitario Marqués de Valdecilla, Complexo Hospitalario de Ourense, Complejo Universitario Torrecárdenas, Almería, Gendiag, Ferrer inCode, S.L., Unitat d'Hemostasia i Trombosi. Hospital de la Santa Creu i Sant Pau, LEO Pharma, Sociedad Española de Trombosis y Hemostasia (SETH), Sociedad Española de Oncología Médica (SEOM), University Hospital Virgen de las Nieves, Hospital Obispo Polanco, Complejo Hospitalario Universitario de Vigo, Hospital General Universitario Elche, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz, Hospital General de Ciudad Real
- Study start
- Mar 2013
- Primary completion
- Dec 2020 (actual)
- Study completion
- Feb 2021 (actual)
- First posted
- 14 Apr 2017 (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.
Venous thromboembolism (VTE) is a common disease in cancer patients and one of the major causes of cancer-associated mortality. Risk for developing VTE increases when cancer patients are receiving chemotherapy. Current risk scores for predicting cancer-associated VTE in ambulatory patients had low/moderate discrimination and clinical sensitivity. These models use clinical and biochemical parameters of the patient.
In the development of VTE genetics play a relevant role. The product Thrombo inCode (TiC) assess VTE risk prediction by using a combination of a genetic risk score (GRS) and clinical parameters from the patient. The investigators hypothesized that the GRS included in TiC combined with clinical parameter some of them associated with cancer could be better predicted by TiC than by current risk scores (Khorana score).
After publishing the primary results in 2018, we have expanded the GRS in a external validation cohort adding gliomas and biliary tract tumors. Also we have incorporated the assessment of D-dimer in order to improve the predictive capability.
Detailed description
The working hypothesis of this study establishes that the risk of cancer patients suffering a thromboembolic event is conditioned by individual genomic factors. The genes to be analyzed have clearly demonstrated their relationship with thromboembolic disease in other clinical contexts. This study is considered the initiation of a field of research in genomic risk markers indicating a risk of thrombosis in cancer patients. The ultimate goal of the study is to establish a clinic-genomic score for selecting patients with a high risk of suffering thrombotic events who can benefit from guided thromboprophylaxis. Its secondary goal is to prevent the adverse effects of ineffective therapies in other patients (low-risk patients not requiring an anti-thrombotic prophylaxis).
The aim is to demonstrate the link between the clinic-genetic profile and the risk of suffering thromboembolic events in the group of cancer patients. The working hypothesis establishes that cancer patients who develop thrombotic events will have a higher score for the thrombosis risk clinic-genetic profile than cancer patients not developing thromboembolic events. The second aim is to analyze whether the thrombosis clinic-genetic risk score improves the detection of patients at risk of suffering a thromboembolic event compared to the Khorana predictive model routinely used (Khorana score).
Current validations ongoing:
An external retrospective validation adding 250 patients more and including D-dimer and other types of high-risk neoplasm.
An external prospective validation (second ONCOTRHROMB12-01 cohort 2) adding 450 patients more and including D-dimer and other types of high-risk neoplasm.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include patients diagnosed with colorectal, esophago-gastric, biliary tract, pancreas or lung cancer who have not previously been treated with chemotherapy or chemotherapy and radiation therapy and are candidate for chemotherapy in outpatient setting
Key inclusion criteria (4 listed)
- Patients over 18 years of age.
- Patients treated in outpatient clinics with a documented histological or cytological diagnosis for non-microcytic lung, colorectal, biliary tract cancer, pancreatic or esophago-gastric cancer at an advanced stage, locally advanced or localized not previously treated with systemic chemotherapy and/or radiation therapy who are candidate for chemotherapy in outpatient setting.
- Performance status 0-2.
- Patients signing the study informed consent form.
Key exclusion criteria (2 listed)
- Life expectancy of less than 3 months.
- Patients undergoing anti-coagulant treatment before the cancer diagnosis for reasons other than a concurrent venous thromboembolic event.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Venous thromboembolism events
Time frame: During the 18 months of follow up
The development of venous thromboembolism will be registered
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 14 Apr 2022.
- Results publication: PubMed 25341889Soria JM, Morange PE, Vila J, Souto JC, Moyano M, Tregouet DA, Mateo J, Saut N, Salas E, Elosua R. Multilocus genetic risk scores for venous thromboembolism risk assessment. J Am Heart Assoc. 2014 Oct 23;3(5):e001060. doi: 10.1161/JAHA.114.001060.
- Results publication: PubMed 25652150Rubio-Terres C, Soria JM, Morange PE, Souto JC, Suchon P, Mateo J, Saut N, Rubio-Rodriguez D, Sala J, Gracia A, Pich S, Salas E. Economic analysis of thrombo inCode, a clinical-genetic function for assessing the risk of venous thromboembolism. Appl Health Econ Health Policy. 2015 Apr;13(2):233-42. doi: 10.1007/s40258-015-0153-x.
- Results publication: PubMed 29588512Munoz Martin AJ, Ortega I, Font C, Pachon V, Castellon V, Martinez-Marin V, Salgado M, Martinez E, Calzas J, Ruperez A, Souto JC, Martin M, Salas E, Soria JM. Multivariable clinical-genetic risk model for predicting venous thromboembolic events in patients with cancer. Br J Cancer. 2018 Apr;118(8):1056-1061. doi: 10.1038/s41416-018-0027-8. Epub 2018 Mar 28.
- Derived from this study: PubMed 36730884Munoz A, Ay C, Grilz E, Lopez S, Font C, Pachon V, Castellon V, Martinez-Marin V, Salgado M, Martinez E, Calzas J, Ortega L, Ruperez A, Salas E, Pabinger I, Soria JM. A Clinical-Genetic Risk Score for Predicting Cancer-Associated Venous Thromboembolism: A Development and Validation Study Involving Two Independent Prospective Cohorts. J Clin Oncol. 2023 Jun 1;41(16):2911-2925. doi: 10.1200/JCO.22.00255. Epub 2023 Feb 2.
- Individual participant dataSharing planned: Undecided
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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.
Andrés J. Muñoz Martín, MD PhD principal investigator
Hospital General Universitario Gregorio Marañon
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer-associated Thrombosis and Genetic Predisposition, run by Andres muñoz at 9 sites in Spain.
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 4 inclusion and 2 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 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Spain. 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?
Venous thromboembolism events (time frame: During the 18 months of follow up). 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 NCT03114618, which also lists 4 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 14 Apr 2022.