AdenocarcinomaPROSPECTNCT02785757
Cancer-related Thromboembolic Disease
A study testing Thrombin Generation Assay in people with Adenocarcinoma, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Patients with cancer are at particularly high risk of venous thromboembolism (VTE). The guidelines therefore strongly recommend thromboprophylaxis but recent surveys clearly show that oncologists are reluctant to use it because of concern over bleeding, absence of validated risk stratification tools and uncertainties… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma
- What is being tested?
- Thrombin Generation Assay
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jul 2014to 12 Feb 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients of both sexes with locally advanced or metastatic adenocarcinoma of any origin, who are scheduled for systemic chemotherapy
- Subjects having signed Informed Consent prior to initiation of any study procedure
- Covered by a Health System
Who cannot join
- Known bleeding or thrombophilia disorders
- Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3
- Patient immobilized
- Confirmed venous thromboembolism in the last 12 months
- Active bleeding or bleedings in the last 4 weeks requiring hospitalization, transfusion, or surgical intervention
- Anticoagulant therapy at the moment of first sampling (at least one day off for Heparines and DOAc; at least 5 days off for VKA is needed)
Show all 10Show fewer
- Antiplatelet therapy at the moment of first sampling (only if PRP TGA can be performed at site)
- Severe hepatic insufficiency
- Life expectancy of less than 3 months
- Pregnancy
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Unité d'Hémostase Clinique Hôpital Louis Pradel
Bron, 69500
Yesim Dargaud, MD, PhD, (0)4 72 11 88 25 ext. +33, ydargaud@univ-lyon1.fr
Yesim Dargaud, MD, PhD
About this study
Official title: The Challenge of Cancer-related Thromboembolic Disease: Can we Better Predict the Risk?
Patients with cancer are at particularly high risk of venous thromboembolism (VTE). The guidelines therefore strongly recommend thromboprophylaxis but recent surveys clearly show that oncologists are reluctant to use it because of concern over bleeding, absence of validated risk stratification tools and uncertainties concerning the optimal thromboprophylaxis. Hence, it is a real challenge to identify the individual VTE risk of each cancer patient and individually tailor their thromboprophylaxis.
The study aims to identify thrombin generation test (TGT) as a reliable, standardized overall haemostasis assay that can be used to evaluate individual thrombosis risk
Read more
The secondary objectives are:
- To define the limits of TGT parameters that indicate thrombosis risk in cancer patients
- To evaluate values of other clotting activation markers in patients with cancer
Patients recently diagnosed with locally advanced or metastatic adenocarcinoma of any origin, who are scheduled for systemic chemotherapy, will be enrolled in the trial at baseline (Visit 1). Thrombin generating capacity will be measured within the first month following diagnosis and before the start of the chemotherapy (between Visit 1 and Visit 2) and subsequently at the end of the first cure line of chemotherapy (Visit 3). Patients will be followed up for a period of 1 year, or until the occurrence of a thromboembolic event. Two follow up visits are foreseen - 6-month (Visit 4) and 12-month (or at the end of trial - Visit 5) visits.
Patients eventually undergoing second-line chemotherapy during the course of the follow-up will remain on study.
The study will document all cases of symptomatic thromboembolic events together with the relevant diagnostic work-up.
- Conditions
- Adenocarcinoma
- Being tested
- Thrombin Generation Assay
- Keywords
- adenocarcinoma, venous thromboembolism, thrombin generation assay
- Medical subject headings
- Adenocarcinoma, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thrombin Generation AssayOther
| Study group | Role | What they receive |
|---|---|---|
| Patients with adenocarcinoma | Experimental | 60 Patients recently diagnosed with locally advanced or metastatic adenocarcinoma of any origin, who are scheduled for systemic chemotherapy Receives: Other: Thrombin Generation Assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
thrombin generation assay results
Measured: 7 months
Secondary outcomes (3)
Clotting activation markers: thrombin-antithrombin complexes (TAT)
Measured: 7 months
Clotting activation markers: prothrombin fragment F1+2
Measured: 7 months
Clotting activation markers: D-dimer
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2016 (estimated)
- Study start12 Jul 2014
- Primary completion12 Feb 2024 (estimated)
- Study completion12 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02785757
- Sponsor's protocol ID
- 2012.788
- Other IDs
- 2013-A00065-40
- Acronym
- PROSPECT
- Status last verified
- Jan 2021
- First submitted
- 25 May 2016
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Challenge of Cancer-related Thromboembolic Disease: Can we Better Predict the Risk?
- ClinicalTrials.gov ID
- NCT02785757
- Acronym / sponsor ID
- PROSPECT / 2012.788
- Conditions
- Adenocarcinoma
- Keywords
- adenocarcinoma, venous thromboembolism, thrombin generation assay
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 12 Jul 2014 (actual)
- Primary completion
- 12 Feb 2024 (estimated)
- Study completion
- 12 Feb 2024 (estimated)
- First posted
- 30 May 2016 (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.
Patients with cancer are at particularly high risk of venous thromboembolism (VTE). The guidelines therefore strongly recommend thromboprophylaxis but recent surveys clearly show that oncologists are reluctant to use it because of concern over bleeding, absence of validated risk stratification tools and uncertainties concerning the optimal thromboprophylaxis. Hence, it is a real challenge to identify the individual VTE risk of each cancer patient and individually tailor their thromboprophylaxis.
The study aims to identify thrombin generation test (TGT) as a reliable, standardized overall haemostasis assay that can be used to evaluate individual thrombosis risk
The secondary objectives are:
- To define the limits of TGT parameters that indicate thrombosis risk in cancer patients
- To evaluate values of other clotting activation markers in patients with cancer
Patients recently diagnosed with locally advanced or metastatic adenocarcinoma of any origin, who are scheduled for systemic chemotherapy, will be enrolled in the trial at baseline (Visit 1). Thrombin generating capacity will be measured within the first month following diagnosis and before the start of the chemotherapy (between Visit 1 and Visit 2) and subsequently at the end of the first cure line of chemotherapy (Visit 3). Patients will be followed up for a period of 1 year, or until the occurrence of a thromboembolic event. Two follow up visits are foreseen - 6-month (Visit 4) and 12-month (or at the end of trial - Visit 5) visits.
Patients eventually undergoing second-line chemotherapy during the course of the follow-up will remain on study.
The study will document all cases of symptomatic thromboembolic events together with the relevant diagnostic work-up.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with adenocarcinoma | Experimental | Other: Thrombin Generation Assay60 Patients recently diagnosed with locally advanced or metastatic adenocarcinoma of any origin, who are scheduled for systemic chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients of both sexes with locally advanced or metastatic adenocarcinoma of any origin, who are scheduled for systemic chemotherapy
- Subjects having signed Informed Consent prior to initiation of any study procedure
- Covered by a Health System
Key exclusion criteria (10 listed)
- Known bleeding or thrombophilia disorders
- Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3
- Patient immobilized
- Confirmed venous thromboembolism in the last 12 months
- Active bleeding or bleedings in the last 4 weeks requiring hospitalization, transfusion, or surgical intervention
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 |
|---|---|---|
| Thrombin Generation Assay | Other | Patients with adenocarcinoma |
Primary outcome
thrombin generation assay results
Time frame: 7 months
3 secondary outcomes
Clotting activation markers: thrombin-antithrombin complexes (TAT)
Time frame: 7 months
Clotting activation markers: prothrombin fragment F1+2
Time frame: 7 months
Clotting activation markers: D-dimer
Time frame: 7 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thrombin Generation Assay in people with Adenocarcinoma, run by Hospices Civils de Lyon at 1 site in France.
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 3 inclusion and 10 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 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 Yesim DARGAUD, MD PHD ((0)4 72 11 88 25 ext. +33, ydargaud@univ-lyon1.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
thrombin generation assay results (time frame: 7 months). 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 6 Jan 2021.