Healthy Blood DonorsHYPERCANNCT02622815
Hypercoagulation Screening in Cancer
An observational study of Healthy Blood Donors and Moli-sani Subjects, run by A.O. Ospedale Papa Giovanni XXIII at 8 sites in Italy.
Trial summary
There is a complex, mutual relationship between cancer and thrombosis. Indeed, the tumor has the capacity to activate the hemostatic system and this leads to an increased thrombotic risk in cancer patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Healthy Blood Donors, Moli-sani Subjects, Cancer Patients
- How many people
- 16,000 participants
- Where
- 8 sitesItaly
- Study dates
- Apr 2012to Jan 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Blood donors (age range 30-70 years), who agree to participate, fulfill a specific questionnaire on their lifestyle and donate venous blood samples at the enrollment into the study, and after 6-12 months. The parental cohort of the Moli-sani project included 24,325 subjects (>35 years) from the Molise region. Blood samples have been collected and stored in the Moli-sani biobank available to this project. Cancer patients of both genders (>18 years) with new diagnosis of non small cell lung cancer, gastrointestinal tumors, and breast cancer are enrolled at different recruiting sites. Blood samples are collected at the enrollment and at specific time points during follow-up without interfering with clinical management.
Who may be able to join
- good health
- signed informed consent.
- Exclusion Criteria: (considering 10-15 days from blood sampling)
- inflammations/infections/fever;
- recent vaccinations;
- recent surgery;
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- anticoagulant therapy.
- Cancer patients
- with life expectation higher than 3 months;
- patients with breast, lung or gastrointestinal tumors candidated for chemotherapy regimen;
- ECOG PS 0-2;
- adeguate bone marrow and renal function;
- signed informed consent.
Who cannot join
- acute medical illness;
- terminal conditions or life expectancy less than 3 months;
- under low molecular weight heparin at therapeutic dosage.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Italy8 sites, 7 recruiting
- Recruiting
Papa Giovanni XXIII Hospital - Oncology Unit
Bergamo, 24127
Roberto Labianca, MD, rlabianca@asst-pg23.it
Carlo Tondini, MD, ctondini@asst-pg23.it
- Recruiting
Papa Giovanni XXIII Hospital - S.I.M.T.
Bergamo, 24127
Anna Falanga, MD, annafalanga@icthic.com
Carmen J. Tartari, PhD, aircfalanga@gmail.com
- Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
Filippo De Braud, MD, filippo.debraud@istitutotumori.mi.it
Luigi Celio, MD, luigi.celio@istitutotumori.mi.it
- Recruiting
Istituti Ospedalieri Bergamaschi S.r.l. - Policlinico San Marco
Osio Sotto, Bergamo, 24040
Andrea D'Alessio, MD, dr.dalessio@gmail.com
Sara Cecchini, MD, saracecchini@hotmail.it
- Active, not recruiting
I.R.C.C.S. Istituto Neurologico Mediterraneo NEUROMED
Pozzilli, Isernia, 86077
- Recruiting
ASL Roma 1 - ACO San Filippo Neri & San Giovanni Maria Addolorata Hospital
Rome, 00135
Giampietro Gasparini, MD, gasparini.oncology@hotmail.it
Roberta Sarmiento, MD, roberta.sarmiento@yahoo.it
- Recruiting
Fondazione Humanitas per la Ricerca
Rozzano, Milan, 20089
Armando Santoro, MD, armando.santoro@cancercenter.humanitas.it
Giovanna Masci, MD, giovanna.masci@cancercenter.humanitas.it
- Recruiting
A.S.S.T. Bergamo Ovest
Treviglio, Bergamo, 24047
Fausto Fausto, MD, fausto_petrelli@asst-bgovest.it
Mara Ghilardi, MD, mara.ghily@asst-bgovest.it
About this study
Official title: Hypercoagulation Screening as Innovative Tool for Risk Assessment, Early Diagnosis and Prognosis in Cancer
There is a complex, mutual relationship between cancer and thrombosis. Indeed, the tumor has the capacity to activate the hemostatic system and this leads to an increased thrombotic risk in cancer patients. Even in the absence of clinical manifestations, cancer patients are commonly characterized by hemostatic abnormalities, recognized only by laboratory testing, which define the 'hypercoagulable state'. Of interest, hypercoagulation has been repeatedly reported to be associated with tumor progression and poor prognosis in various carcinomas. On the other hand, thrombotic event can represent the first signal of the presence of an occult tumor. These findings suggest that the coagulant pathway might play a role in the preclinical phase of cancer. The investigators hypothesize that a persistent, subclinical activation of the hemostatic system in an otherwise healthy subject, may predispose not only to thrombosis, but also to tumor formation and spreading. A major problem in primary cancer prevention is the lack of effective predictive markers of the disease. The HYPERCAN is an ongoing prospective Italian multicenter study organized around two tightly-interconnected research programs aiming to: 1_the assessment of thrombotic markers as a tool for cancer risk prediction in two large populations of healthy subjects, i.e. a group of healthy blood donors of Bergamo and Milano Provinces and a subgroup of Moli-sani subjects of the Molise region; and 2_ the evaluation whether thrombotic markers and/or the occurrence of overt thrombosis (or disseminated intravascular coagulation) may be prognostic of cancer disease outcomes (i.e. overall survival, progression free survival in metastatic cancer, disease free survival in limited disease) in cancer patients with different types of solid tumors (i.e. breast, lung and gastrointestinal cancers).
Therefore, the assessment of cancer risk occurrence in healthy individuals might be useful for anticipation of cancer diagnosis. In addition, the results of this study might help to evaluate whether thrombotic markers may be prognostic of cancer outcomes independently of the disease extension.
- Conditions
- Healthy Blood Donors, Moli-sani Subjects, Cancer Patients
- Keywords
- Hypercoagulation, Thrombosis, Cancer Risk Assessment, Cancer Prognosis
- Medical subject headings
- Thrombophilia, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy blood donors | 10,000 highly controlled blood donors in the age range 30-70 years | |
| Moli-sani subjects | A sample of 1,000 tumor cases have been identified so far and samples from these participants will be analyzed compared to 1,000 controls from randomly extracted from the Moli-sani cohort (parent cohort). | |
| Cancer patients | 4,000 Patients with breast, lung, and gastrointestinal tumors. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of blood donors with a diagnosis of cancer
Samples collected from identified participants with cancer diagnosis will be assessed to determine the hypercoagulation profile (ratio for laboratory analysis cancer case : healthy control from same cohort = 1:3, matched for age and gender)
Measured: within 5 years from the date of the enrollment
Incidence of Thrombotic events among enrolled cancer patients
Identification of cancer patients with evidence of thrombotic event derived from review of clinical records.
Measured: within 5 years from the date of the enrollment
Secondary outcomes (1)
Incidence of Cancer progression among enrolled cancer patients
Identification of cancer patients with evidence of cancer progression derived from review of clinical records.
Measured: within 5 years from the date of the enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2015 (estimated)
- Study startApr 2012
- Primary completionDec 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Blood DonorsStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 16,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- A.O. Ospedale Papa Giovanni XXIII
- Sponsor type
- University, hospital or other
- Collaborators
- Associazione Italiana per la Ricerca sul Cancro, Istituto Neurologico Mediterraneo Neuromed S. R. L, Fondazione Humanitas per la Ricerca, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, ASL Roma 1, Istituti Ospedalieri Bergamaschi Srl, ASST Bergamo Ovest, Istituti Tumori Giovanni Paolo II
- Responsible party
- Principal investigator, ANNA FALANGA, Papa Giovanni XXIII Hospital
- Investigators
- Anna Falanga, MD, Principal investigator, A.O. Papa Giovanni XXIII - Recruiting
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02622815
- Sponsor's protocol ID
- AIRC5xmille - 12237
- Acronym
- HYPERCAN
- Status last verified
- Oct 2018
- First submitted
- 24 Nov 2015
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypercoagulation Screening as Innovative Tool for Risk Assessment, Early Diagnosis and Prognosis in Cancer
- ClinicalTrials.gov ID
- NCT02622815
- Acronym / sponsor ID
- HYPERCAN / AIRC5xmille - 12237
- Conditions
- Healthy Blood Donors, Moli-sani Subjects, Cancer Patients
- Keywords
- Hypercoagulation, Thrombosis, Cancer Risk Assessment, Cancer Prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 16,000 participants (estimated)
- Lead sponsor
- A.O. Ospedale Papa Giovanni XXIIIUniversity, hospital or other
- Collaborators
- Associazione Italiana per la Ricerca sul Cancro, Istituto Neurologico Mediterraneo Neuromed S. R. L, Fondazione Humanitas per la Ricerca, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, ASL Roma 1, Istituti Ospedalieri Bergamaschi Srl, ASST Bergamo Ovest, Istituti Tumori Giovanni Paolo II
- Study start
- Apr 2012 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 7 Dec 2015 (estimated)
- 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.
There is a complex, mutual relationship between cancer and thrombosis. Indeed, the tumor has the capacity to activate the hemostatic system and this leads to an increased thrombotic risk in cancer patients. Even in the absence of clinical manifestations, cancer patients are commonly characterized by hemostatic abnormalities, recognized only by laboratory testing, which define the 'hypercoagulable state'. Of interest, hypercoagulation has been repeatedly reported to be associated with tumor progression and poor prognosis in various carcinomas. On the other hand, thrombotic event can represent the first signal of the presence of an occult tumor. These findings suggest that the coagulant pathway might play a role in the preclinical phase of cancer. The investigators hypothesize that a persistent, subclinical activation of the hemostatic system in an otherwise healthy subject, may predispose not only to thrombosis, but also to tumor formation and spreading. A major problem in primary cancer prevention is the lack of effective predictive markers of the disease. The HYPERCAN is an ongoing prospective Italian multicenter study organized around two tightly-interconnected research programs aiming to: 1_the assessment of thrombotic markers as a tool for cancer risk prediction in two large populations of healthy subjects, i.e. a group of healthy blood donors of Bergamo and Milano Provinces and a subgroup of Moli-sani subjects of the Molise region; and 2_ the evaluation whether thrombotic markers and/or the occurrence of overt thrombosis (or disseminated intravascular coagulation) may be prognostic of cancer disease outcomes (i.e. overall survival, progression free survival in metastatic cancer, disease free survival in limited disease) in cancer patients with different types of solid tumors (i.e. breast, lung and gastrointestinal cancers).
Therefore, the assessment of cancer risk occurrence in healthy individuals might be useful for anticipation of cancer diagnosis. In addition, the results of this study might help to evaluate whether thrombotic markers may be prognostic of cancer outcomes independently of the disease extension.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy blood donors | – | –10,000 highly controlled blood donors in the age range 30-70 years |
| Moli-sani subjects | – | –A sample of 1,000 tumor cases have been identified so far and samples from these participants will be analyzed compared to 1,000 controls from randomly extracted from the Moli-sani cohort (parent cohort). |
| Cancer patients | – | –4,000 Patients with breast, lung, and gastrointestinal tumors. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Blood donors (age range 30-70 years), who agree to participate, fulfill a specific questionnaire on their lifestyle and donate venous blood samples at the enrollment into the study, and after 6-12 months. The parental cohort of the Moli-sani project included 24,325 subjects (>35 years) from the Molise region. Blood samples have been collected and stored in the Moli-sani biobank available to this project. Cancer patients of both genders (>18 years) with new diagnosis of non small cell lung cancer, gastrointestinal tumors, and breast cancer are enrolled at different recruiting sites. Blood samples are collected at the enrollment and at specific time points during follow-up without interfering with clinical management.
Key inclusion criteria (13 listed)
- good health
- signed informed consent.
- Exclusion Criteria: (considering 10-15 days from blood sampling)
- inflammations/infections/fever;
- recent vaccinations;
Key exclusion criteria (3 listed)
- acute medical illness;
- terminal conditions or life expectancy less than 3 months;
- under low molecular weight heparin at therapeutic dosage.
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
Number of blood donors with a diagnosis of cancer
Time frame: within 5 years from the date of the enrollment
Samples collected from identified participants with cancer diagnosis will be assessed to determine the hypercoagulation profile (ratio for laboratory analysis cancer case : healthy control from same cohort = 1:3, matched for age and gender)
Incidence of Thrombotic events among enrolled cancer patients
Time frame: within 5 years from the date of the enrollment
Identification of cancer patients with evidence of thrombotic event derived from review of clinical records.
1 secondary outcome
Incidence of Cancer progression among enrolled cancer patients
Time frame: within 5 years from the date of the enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
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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.
Anna Falanga, MD principal investigator
A.O. Papa Giovanni XXIII - Recruiting
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Blood Donors and Moli-sani Subjects, run by A.O. Ospedale Papa Giovanni XXIII at 8 sites in Italy.
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 13 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 29 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Falanga, MD (+39-035.267.8597, annafalanga@icthic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of blood donors with a diagnosis of cancer (time frame: within 5 years from the date of the enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2018.