Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03134820
Other study ID # Hispalis study
Secondary ID
Status Completed
Phase N/A
First received April 26, 2017
Last updated April 26, 2017
Start date December 15, 2015
Est. completion date March 31, 2017

Study information

Verified date April 2017
Source Delos Clinical
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Cancer is the most important acquired risk factor of thromboembolisms. More than 20% of all episodes of venous thromboembolism (VT) or pulmonary thromboembolisms (PT) are cancer related. Cancer patients with VT or PT are treated with low molecular weight heparins (LMWH) during at least 3 months, but nowadays the duration of treatment is not accurately determined.

The D-Dimer determination has been used like recurrence predictors after LMWH treatment suspension, but in cancer patients the useful is limited. Phospholipid-dependent microparticles could been used like recurrence predictors in cancer patients and tailored the duration of LMWH treatment for each patient.


Description:

We are carrying out a study in Cancer-associated-thromboembolism patients in order to decide the suitable anticoagulation time. A set of exclusion criteria is being used to determine in which patients LMWH will be withdrawn. Patients are being followed after LMWH withdrawal until 6 months. Blood samples are being taken at baseline (LMWH withdrawal), 3 weeks and 3 months after. We will look for association between several biomarkers and venous thromboembolism recurrences.


Recruitment information / eligibility

Status Completed
Enrollment 352
Est. completion date March 31, 2017
Est. primary completion date December 31, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient with diagnosis of cancer (any) and diagnosis of pulmonary thromboembolism (PT) or venous thromboembolism (VT) , in treatment with low molecular weight heparin (LMWH).

- Patients treated with LMWH since cancer diagnostic.

- Signed informed consent sheet

Exclusion Criteria:

- Patients with life expectancy lower than 6 months

- Pregnancy woman

- Patients with cerebral metastasis

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Delos Clinical

Outcome

Type Measure Description Time frame Safety issue
Primary Recurrence thromboembolisms Venous thromboembolisms or Pulmonary thromboembolism recurrence after LMWH suppression 3 months
Primary Recurrence thromboembolisms Venous thromboembolisms or Pulmonary thromboembolism recurrence after LMWH suppression 6 months
Secondary Hemorrhagic events Hemorrhagic events due to LMWH treatment 6 months
Secondary Thromboembolic event attributable death Death related to embolic event 6 months
See also
  Status Clinical Trial Phase
Recruiting NCT05346796 - Survivorship Plan HEalth REcord (SPHERE) Implementation Trial N/A
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Completed NCT04867850 - Effect of Behavioral Nudges on Serious Illness Conversation Documentation N/A
Enrolling by invitation NCT04086251 - Remote Electronic Patient Monitoring in Oncology Patients N/A
Completed NCT01285037 - A Study of LY2801653 in Advanced Cancer Phase 1
Completed NCT00680992 - Study of Denosumab in Subjects With Giant Cell Tumor of Bone Phase 2
Completed NCT00062842 - Study of Irinotecan on a Weekly Schedule in Children Phase 1
Active, not recruiting NCT04548063 - Consent Forms in Cancer Research: Examining the Effect of Length on Readability N/A
Completed NCT04337203 - Shared Healthcare Actions and Reflections Electronic Systems in Survivorship N/A
Recruiting NCT04349293 - Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways N/A
Terminated NCT02866851 - Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy N/A
Active, not recruiting NCT05304988 - Development and Validation of the EFT for Adolescents With Cancer
Completed NCT04448041 - CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
Completed NCT00340522 - Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
Recruiting NCT04843891 - Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis. Phase 1
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Completed NCT03109041 - Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source Phase 1
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Terminated NCT01441115 - ECI301 and Radiation for Advanced or Metastatic Cancer Phase 1
Recruiting NCT06206785 - Resting Energy Expenditure in Palliative Cancer Patients