Local CancerARIASNCT05806632
Prognostic Relevance of Coagulation Activation in RIsk Assessment and Stratification
An observational study of Local Cancer, run by Regina Elena Cancer Institute at 3 sites in Italy.
Trial summary
Carcinogenesis and coagulation activation are closely related processes. In a previous study of coagulation activation in stage I-IIA breast cancer patients, we developed a prognostic model that includes coagulation activation biomarkers and demonstrated efficacy to in distinguish between risk categories and survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Local Cancer
- What is being tested?
- Prognostic model
- How many people
- 108 participants
- Where
- 3 sitesItaly
- Study dates
- 21 Jan 2020to 31 Dec 2023
- How long will I take part?
- 24 Months
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stage IIB-IIIC breast cancer undergoing neoadjuvant chemotherapy (NACT), followed by breast surgery
Who may be able to join
- Patients with normal organ functions
- Cytologically/histologically proven breast cancer, stage IIB-IIIC
- Participants must not have prophylactic or therapeutic indications for anticoagulants.
Who cannot join
- Pregnacy
- Metastatic breast cancer
- Previous chemotherapy, hormone therapy, radiotherapy
- Previous malignancies or contralateral breast cancer
Trial locations and contacts
3 sites in 1 country.
Italy3 sites, 3 recruiting
- Recruiting
Policlinico Umberto I
Roma, 00161
Paolo Marchetti
- Recruiting
Policlinico Agostino Gemelli
Roma, 00168
Paola Cassano
- Recruiting
"Regina Elena" National Cancer Institute
Rome, 00144
About this study
Official title: Prognostic Relevance of Coagulation Activation in RIsk Assessment and Stratification in Reference to Patient Important Outcomes for Locally Advanced Breast Cancer: The ARIAS Trial
Carcinogenesis and coagulation activation are closely related processes. In a previous study of coagulation activation in stage I-IIA breast cancer patients, we developed a prognostic model that includes coagulation activation biomarkers and demonstrated efficacy to in distinguish between risk categories and survival. Here, we propose a study useful for the validation of this prognostic model in an independent cohort of 108 patients with locally advanced breast cancer and indicated for neoadjuvant chemotherapy, followed by breast surgery. Within this study population, we will validate our prognostic model for risk assessment and risk stratification with respect to the following endpoints:
- Complete pathological response rate to definitive breast surgery;
- Rate of thromboembolic events.
- Conditions
- Local Cancer
- Being tested
- Prognostic model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prognostic modelOther
Risk assessment and risk stratification
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological response rate
The study will mainly aim to validate the accuracy of previous developed prognostic model in distinguish between risk categories and probabilities of pathological complete response (pCR) detected in patients undergoing neoadjuvant chemotherapy (NACT) and breast surgery.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start21 Jan 2020
- Primary completion22 Dec 2022
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local CancerStudies 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
- 108 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05806632
- Sponsor's protocol ID
- RS1307/20
- Acronym
- ARIAS
- Status last verified
- Mar 2023
- First submitted
- 28 Mar 2023
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Relevance of Coagulation Activation in RIsk Assessment and Stratification in Reference to Patient Important Outcomes for Locally Advanced Breast Cancer: The ARIAS Trial
- ClinicalTrials.gov ID
- NCT05806632
- Acronym / sponsor ID
- ARIAS / RS1307/20
- Conditions
- Local Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 10 Apr 2023 (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.
Carcinogenesis and coagulation activation are closely related processes. In a previous study of coagulation activation in stage I-IIA breast cancer patients, we developed a prognostic model that includes coagulation activation biomarkers and demonstrated efficacy to in distinguish between risk categories and survival. Here, we propose a study useful for the validation of this prognostic model in an independent cohort of 108 patients with locally advanced breast cancer and indicated for neoadjuvant chemotherapy, followed by breast surgery. Within this study population, we will validate our prognostic model for risk assessment and risk stratification with respect to the following endpoints:
- Complete pathological response rate to definitive breast surgery;
- Rate of thromboembolic events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stage IIB-IIIC breast cancer undergoing neoadjuvant chemotherapy (NACT), followed by breast surgery
Key inclusion criteria (3 listed)
- Patients with normal organ functions
- Cytologically/histologically proven breast cancer, stage IIB-IIIC
- Participants must not have prophylactic or therapeutic indications for anticoagulants.
Key exclusion criteria (4 listed)
- Pregnacy
- Metastatic breast cancer
- Previous chemotherapy, hormone therapy, radiotherapy
- Previous malignancies or contralateral breast cancer
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 |
|---|---|---|
| Prognostic modelRisk assessment and risk stratification | Other | – |
Primary outcome
Pathological response rate
Time frame: 30 months
The study will mainly aim to validate the accuracy of previous developed prognostic model in distinguish between risk categories and probabilities of pathological complete response (pCR) detected in patients undergoing neoadjuvant chemotherapy (NACT) and breast surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Local Cancer, run by Regina Elena Cancer Institute at 3 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 3 inclusion and 4 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 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 Patrizia Vici, MD (+39 06 52665698, patrizia.vici@ifo.gov.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological response rate (time frame: 30 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 10 Apr 2023.