Hypercoagulation Screening in Cancer (HYPERCAN)

October 26, 2018 updated by: ANNA FALANGA, A.O. Ospedale Papa Giovanni XXIII

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

16000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Blood donors_

Inclusion Criteria:

  • good health
  • signed informed consent.

Exclusion Criteria: (considering 10-15 days from blood sampling)

  • inflammations/infections/fever;
  • recent vaccinations;
  • recent surgery;
  • anticoagulant therapy.

Cancer patients_

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • acute medical illness;
  • terminal conditions or life expectancy less than 3 months;
  • under low molecular weight heparin at therapeutic dosage.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
within 5 years from the date of the enrollment
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.
within 5 years from the date of the enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Cancer progression among enrolled cancer patients
Time Frame: within 5 years from the date of the enrollment
Identification of cancer patients with evidence of cancer progression derived from review of clinical records.
within 5 years from the date of the enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

A.O. Ospedale Papa Giovanni XXIII

Collaborators

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Associazione Italiana per la Ricerca sul Cancro
Istituti Tumori Giovanni Paolo II
Istituto Neurologico Mediterraneo Neuromed S. R. L
ASL Roma 1
ASST Bergamo Ovest
Fondazione Humanitas per la Ricerca
Istituti Ospedalieri Bergamaschi Srl

Investigators

  • Principal Investigator: Anna Falanga, MD, A.O. Papa Giovanni XXIII - Recruiting

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2012

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

November 24, 2015

First Submitted That Met QC Criteria

December 4, 2015

First Posted (Estimate)

December 7, 2015

Study Record Updates

Last Update Posted (Actual)

October 29, 2018

Last Update Submitted That Met QC Criteria

October 26, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIRC5xmille - 12237

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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