Breast CancerVISION INCT04289935
Intelligent Vacuum Assisted Biopsy Immediately Before Surgery As an Intra- or Pre-Operative Surrogate for Patient Response to Neoadjuvant Chemotherapy for Breast Cancer
A study testing Vacuum assisted biopsy (VAB) in people with Breast Cancer, run by Klinik Hirslanden, Zurich at 26 sites in 4 countries.
Trial summary
Neoadjuvant chemotherapy (NAC) is common practice in the primary treatment of breast cancer, leading to a complete pathologic remission (pCR) of the tumor in more than 50% in aggressive tumor types. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Vacuum assisted biopsy (VAB)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 26 sitesin 4 countries
- Study dates
- 17 Aug 2020to Jun 2025
- 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
- Written informed consent according to ICH/GCP regulations before registration and prior to any trial specific procedures
- unifocal, histologically confirmed invasive breast cancer with IHC luminal B (with or without overexpression or amplification of the HER2 receptor) and all ER negative (ER < 10%) breast cancers
- Initial tumor size larger than 1 and less than 5 cm (cT1c to cT2), any N, M0
- Clipping of the primary tumor center prior to the start of neo-adjuvant chemotherapy
- Neo-adjuvant chemotherapy resulting in a radiological complete response or near complete response on MR-Imaging (confirmed within 28 days before or on registration) as described in the trial specific MR-Imaging instructions (available on the welcome page of the study specific SecuTrial link). MRI is strongly recommended, alternative ultrasound
- Former tumor bed must be accessible for biopsy
Show all 9Show fewer
- Female or male aged ≥ 18 years
- Adequate condition for breast cancer surgery
- Patients with a previously treated malignancy are eligible, when the risk of the prior malignancy interfering with either safety or efficacy endpoints is very low
Who cannot join
- Metastatic breast cancer
- Multifocal/Multicentric breast cancer
- Inflammatory breast cancer
- Luminal-A types of breast cancers (ER ≥ 10% and PgR ≥ 10 % and G1 or 2, and/or Ki-67 ≤ 20%, HER2 negative) or low risk if assessed by a validated genomic prognostic test (e.g. Mammaprint, Endopredict, Oncotype or Nanostring)
- Distinct radiological sign of residual disease in the breast after neo-adjuvant chemotherapy by imaging
- Intra-/peritumoral microcalcifications larger than 2 cm at time of diagnosis
- Any local therapy (irradiation or surgery) to the currently treated breast prior to the trial intervention
- Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, trial intervention and follow-up, affect patient compliance or place the patient at high risk from trial intervention-related complications
Trial locations and contacts
26 sites in 4 countries.
26 sites in 4 countries
Switzerland18 sites, 18 recruiting
- Recruiting
Tumor Zentrum Aarau
Aarau, 5000
Andreas Jakob, MD, +41 62 836 78 30, andreas.jakob@tumor-zentrum.ch
Andreas Jakob, MD
- Recruiting
Kantonsspital Baden
Baden, 5404
Cornelia Leo, Prof, +41 56 486 35 14, cornelia.leo@ksb.ch
Cornelia Leo, Prof
- Recruiting
Universitätsspital Basel
Basel, 4031
Christian Kurzeder, Prof, +41 61 328 79 90, Christian.kurzeder@usb.ch
Christian Kurzeder, Prof
- Recruiting
Bethesda Spital
Basel, 4052
Dieter Müller, MD, +41 61 823 77 00, dieter.müller@hin.ch
Dieter Müller, MD
- Recruiting
St. Claraspital
Basel
Roberto Rodriguez, MD, +41 61 685 34 53, roberto.rodriguezrevuelto@claraspital.ch
Roberto Rodriguez, MD
- Recruiting
Hirslanden Brustzentrum Bern Biel
Bern, 3013
Patrizia Sager, MD, +41 31 337 89 70, patrizia.sager@hirslanden.ch
Patrizia Sager, MD
- Recruiting
Kantonsspital Graubünden
Chur, 7000
Martina Gabriella Maranta, MD, +41 81 254 81 64, martina.maranta@ksgr.ch
Martina Maranta, MD
- Recruiting
Spital Thurgau AG Frauenfeld und Münsterlingen
Frauenfeld, 8501
Mathias Fehr, Prof, +41 52 723 72 55, mathias.fehr@stgag.ch
Mathias Fehr, Prof
- Recruiting
Clinique de Genolier
Genolier, 1272
Magdalena Kohlik, MD, +41 22 366 93 67, mkohlik@genolier.net
Magdalena Kohlik, MD
- Recruiting
Luzerner Kantonsspital
Lucerne, 6000
Kathrin Schwedler, MD, +41 41 205 12 36, kathrin.schwedler@luks.ch
Kathrin Schwedler, MD
- Recruiting
Hirslanden Klinik St. Anna
Lucerne, 6006
Peter Dubsky, Prof, +41 41 208 37 54, peter.dubsky@hirslanden.ch
Peter Dubsky, Prof
- Recruiting
Ente Ospedaliero Cantonale, Dipartimento di ginecologia e ostretricia
Lugano, 6962
Maria Luisa Gasparri, Prof., +41 91 811 61 54, marialuisa.gasparri@eoc.ch
Maria Luisa Gasparri, Prof.
- Recruiting
Brustzentrum Rheinfelden
Rheinfelden, 4310
Maik Hauschild, MD, +41 61 835 62 20, maik.hauschild@gzf.ch
Maik Hauschild, MD
- Recruiting
Kantonsspital St. Gallen
Sankt Gallen, 9007
Christine Strub, MD, +41 71 494 97 14, christine.strub@kssg.ch
Christine Strub, MD
- Recruiting
Tumor- und BrustZentrum Ostschweiz
Sankt Gallen, 9016
Michael Knauer, Prof, +41 71 552 33 33, michael.knauer@tbz-ost.ch
Michael Knauer, Prof
- Recruiting
Kantonsspital Winterthur
Winterthur, 8401
Denise Vorburger, MD, +41 52 266 31 73, denise.vorburger@ksw.ch
Denise Vorburger, MD
- Recruiting
Brust-Zentrum Seefeld
Zurich, 8008
Christoph Tausch, MD, +41 44 533 81 00, c.tausch@brust-zentrum.ch
Christoph Tausch, MD
- Recruiting
Universitäts Spital Zürich
Zurich, 8091
Heike Frauchiger-Heuer, MD, +41 44 255 42 37, heike.frauchiger-heuer@usz.ch
Heike Frauchiger-Heuer, MD
Germany4 sites, 4 recruiting
- Recruiting
Agaplesion Markus Krankenhaus
Frankfurt, 60431
Marc Thill, Prof., +49 69 9533 2228, marc.thill@agaplesion.de
Marc Thill, Prof.
- Recruiting
Brustzentrum Heidelberg
Heidelberg, 69121
Jörg Heil, Prof., +49 6221 488 60 20, joerg.heil@kse-hd.de
Joerg Heil, Prof.
- Recruiting
UFK Klinikum Südstadt Rostock
Rostock, 18059
Steffi Hartmann, MD, +49 381 4401 47 00, steffi.hartmann@kliniksued-rostock.de
Steffi Hartmann, MD
- Recruiting
Helios Universitätsklinikum Wuppertal
Wuppertal, 42283
Vesna Bjelic-Radisic, Prof., +49 202 896 14 11, vesna.bjelic-radisic@helios-gesundheit.de
Vesna Bjelic-Radisic, Prof.
Austria3 sites, 3 recruiting
- Not yet recruiting
Universitätsspital Salzburg
Salzburg, 5020
Andreas Sir, +43 572 555 74 34, a.sir@salk.at
Andreas Sir, MD
- Recruiting
Brustzentrum Schwaz
Schwaz, 6130
Michael Hubalek, MD, +43 5242 655 290, office@dr-hubalek.at
Michael Hubalek, MD
- Recruiting
St. Josef Krankenhaus Wien
Vienna, 1130
Ulrich Schmidbauer, MD, +43 187 844 8200, ulrich.schmidbauer@sjk-wien.at
Ulrich Schmidbauer, MD
United Arab Emirates1 site, 1 recruiting
- Recruiting
Mediclinic City Hospital Dubai
Dubai
Annett Al-Hamadi, MD, +971 4555 9112, annett.hamadi@mediclinic.ae
Annett Al Hamadi, MD
About this study
Official title: Intelligent Vacuum Assisted Biopsy Immediately Before Surgery As an Intra- or Pre-Operative Surrogate for Patient Response to Neoadjuvant Chemotherapy for Breast Cancer (VISION I): a Multicenter Prospective Feasibility Trial
Neoadjuvant chemotherapy (NAC) is common practice in the primary treatment of breast cancer, leading to a complete pathologic remission (pCR) of the tumor in more than 50% in aggressive tumor types. As NAC induces different response patterns, radiologic imaging is not sufficiently accurate in predicting residual disease. Because of this uncertainty, surgery is so far the only valid option to either ascertain complete response or to remove the complete residual disease.
Vacuum-assisted biopsy (VAB) with the possibility of obtaining tissue of the former tumor center could contribute more reliably to detect any residual tumor or respectively, rule out residual disease. Ultrasound (US) or mammographically (MG) guided VAB will be used in this trial in order to detect residual tumor lesions in patients with radiological complete response (rCR) after NAC. The investigators will evaluate the diagnostic accuracy of the post-NAC VAB sample in comparison to the sample obtained in open surgery.
Read the detailed description
Neoadjuvant chemotherapy (NAC), initially indicated to downstage tumors to achieve the option of breast conserving surgery, has lately become common practice in the primary treatment of breast cancer. The use of modern NAC regimens lead to a complete pathologic remission (pCR) of the tumor in more than 50% in aggressive tumor types.
In general, it is difficult to predict pCR in the absence of invasive surgical techniques, as it depends on several factors such as biological subtype, the used chemotherapy regimen and anatomic stage. The most common imaging methods beside clinical examination are breast ultrasound, mammography and breast magnetic resonance imaging (MRI). As NAC induces different response patterns, radiologic imaging is not sufficiently accurate in predicting residual disease. Because of this uncertainty, surgery (and the standardized assessment of resected tissue) is so far the only valid option to either ascertain complete response or to remove the complete residual disease.
Vacuum-assisted biopsy (VAB) with the possibility of obtaining tissue of the former tumor center could contribute more reliably to detect any residual tumor or respectively, rule out residual disease. Ultrasound (US) or mammographically (MG) guided VAB will be used in this trial in order to detect residual tumor lesions in patients with radiological complete response (rCR) after NAC. The investigators will evaluate the diagnostic accuracy of the post-NAC VAB sample in comparison to the sample obtained in open surgery.
The main objective of the trial is to determine the diagnostic accuracy of I-VAB using the full pathologic specimen evalutation obtained after open surgery to detect residual tissue.
- Conditions
- Breast Cancer
- Being tested
- Vacuum assisted biopsy (VAB)
- Keywords
- Neoadjuvant chemotherapy, VISION I, breast cancer, Vacuum assisted biopsy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vacuum assisted biopsy (VAB)Procedure or surgery
The trial intervention consists of a diagnostic interventional procedure, US-guided or mammographically guided VAB post-NAC, prior to the standard breast surgery.
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | * Unicentric histologically confirmed invasive luminal B, HER2- enriched, triple negative breast cancer + Clipping + Neoadjuvant chemotherapy
* rCR / near-rCR in MRI / US
* Registration
* US-guided VAB
* Breast conserving surgery / mastectomy
* Pathology examination 1. Preoperative VAB, 2. Surgical specimen Receives: Procedure: Vacuum assisted biopsy (VAB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Sensitivity of I-VAB is defined as proportion of true positive patients (Both VAB and surgery showing non pCR) given patients with non pCR assessed using surgical specimen.
Measured: max. 6 weeks after registration
Secondary outcomes (6)
Specificity
Specificity of I-VAB is defined as proportion of true negative patients (Both VAB and surgery showing pCR) given patients with pCR assessed using surgical specimen.
Measured: max. 6 weeks after registration
Positive predictive value (PPV)
PPV of I-VAB is defined as proportion of true positive patients given patients with non pCR assessed using VAB
Measured: max. 6 weeks after registration
Negative predictive value (NPV)
NPV of I-VAB is defined as proportion of true negative patients given patients with pCR assessed using VAB
Measured: max. 6 weeks after registration
Accuracy (ACC)
ACC of I-VAB is defined as the proportion of true positive and true negative patients.
Measured: max. 6 weeks after registration
Surgical lymph node status
Surgical lymph node status (positive vs. negative) is categorized by the pathologist according to surgical specimen.
Measured: max. 6 weeks after registration
Adverse events
Proportion of patients with bleeding/hematoma causing immediate surgical intervention and breast infection, which are related to VAB.
Measured: From US-guided VAB (max. 6 weeks after registration) until 2 weeks after breast surgery (max 1 day after VAB).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start17 Aug 2020
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- multicenter, prospective, single arm, feasibility trial
- Masking
- None (open label)
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klinik Hirslanden, Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Oncoplastic Breast Consortium (OPBC)
- Responsible party
- Principal investigator, PD Dr. med. Christoph Tausch, Klinik Hirslanden, Zurich
- Investigators
- Christoph Tausch, MD, Study chair, Brust-Zentrum, Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04289935
- Sponsor's protocol ID
- HIRSLANDEN 01 OPBC SAKK 23/18
- Acronym
- VISION I
- Status last verified
- Oct 2024
- First submitted
- 25 Feb 2020
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intelligent Vacuum Assisted Biopsy Immediately Before Surgery As an Intra- or Pre-Operative Surrogate for Patient Response to Neoadjuvant Chemotherapy for Breast Cancer (VISION I): a Multicenter Prospective Feasibility Trial
- ClinicalTrials.gov ID
- NCT04289935
- Acronym / sponsor ID
- VISION I / HIRSLANDEN 01 OPBC SAKK 23/18
- Conditions
- Breast Cancer
- Keywords
- Neoadjuvant chemotherapy, VISION I, breast cancer, Vacuum assisted biopsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Klinik Hirslanden, ZurichUniversity, hospital or other
- Collaborators
- Oncoplastic Breast Consortium (OPBC)
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 28 Feb 2020 (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.
Neoadjuvant chemotherapy (NAC) is common practice in the primary treatment of breast cancer, leading to a complete pathologic remission (pCR) of the tumor in more than 50% in aggressive tumor types. As NAC induces different response patterns, radiologic imaging is not sufficiently accurate in predicting residual disease. Because of this uncertainty, surgery is so far the only valid option to either ascertain complete response or to remove the complete residual disease.
Vacuum-assisted biopsy (VAB) with the possibility of obtaining tissue of the former tumor center could contribute more reliably to detect any residual tumor or respectively, rule out residual disease. Ultrasound (US) or mammographically (MG) guided VAB will be used in this trial in order to detect residual tumor lesions in patients with radiological complete response (rCR) after NAC. The investigators will evaluate the diagnostic accuracy of the post-NAC VAB sample in comparison to the sample obtained in open surgery.
Detailed description
Neoadjuvant chemotherapy (NAC), initially indicated to downstage tumors to achieve the option of breast conserving surgery, has lately become common practice in the primary treatment of breast cancer. The use of modern NAC regimens lead to a complete pathologic remission (pCR) of the tumor in more than 50% in aggressive tumor types.
In general, it is difficult to predict pCR in the absence of invasive surgical techniques, as it depends on several factors such as biological subtype, the used chemotherapy regimen and anatomic stage. The most common imaging methods beside clinical examination are breast ultrasound, mammography and breast magnetic resonance imaging (MRI). As NAC induces different response patterns, radiologic imaging is not sufficiently accurate in predicting residual disease. Because of this uncertainty, surgery (and the standardized assessment of resected tissue) is so far the only valid option to either ascertain complete response or to remove the complete residual disease.
Vacuum-assisted biopsy (VAB) with the possibility of obtaining tissue of the former tumor center could contribute more reliably to detect any residual tumor or respectively, rule out residual disease. Ultrasound (US) or mammographically (MG) guided VAB will be used in this trial in order to detect residual tumor lesions in patients with radiological complete response (rCR) after NAC. The investigators will evaluate the diagnostic accuracy of the post-NAC VAB sample in comparison to the sample obtained in open surgery.
The main objective of the trial is to determine the diagnostic accuracy of I-VAB using the full pathologic specimen evalutation obtained after open surgery to detect residual tissue.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- multicenter, prospective, single arm, feasibility trial
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Procedure: Vacuum assisted biopsy (VAB)* Unicentric histologically confirmed invasive luminal B, HER2- enriched, triple negative breast cancer + Clipping + Neoadjuvant chemotherapy * rCR / near-rCR in MRI / US * Registration * US-guided VAB * Breast conserving surgery / mastectomy * Pathology examination 1. Preoperative VAB, 2. Surgical specimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written informed consent according to ICH/GCP regulations before registration and prior to any trial specific procedures
- unifocal, histologically confirmed invasive breast cancer with IHC luminal B (with or without overexpression or amplification of the HER2 receptor) and all ER negative (ER < 10%) breast cancers
- Initial tumor size larger than 1 and less than 5 cm (cT1c to cT2), any N, M0
- Clipping of the primary tumor center prior to the start of neo-adjuvant chemotherapy
- Neo-adjuvant chemotherapy resulting in a radiological complete response or near complete response on MR-Imaging (confirmed within 28 days before or on registration) as described in the trial specific MR-Imaging instructions (available on the welcome page of the study specific SecuTrial link). MRI is strongly recommended, alternative ultrasound
Key exclusion criteria (8 listed)
- Metastatic breast cancer
- Multifocal/Multicentric breast cancer
- Inflammatory breast cancer
- Luminal-A types of breast cancers (ER ≥ 10% and PgR ≥ 10 % and G1 or 2, and/or Ki-67 ≤ 20%, HER2 negative) or low risk if assessed by a validated genomic prognostic test (e.g. Mammaprint, Endopredict, Oncotype or Nanostring)
- Distinct radiological sign of residual disease in the breast after neo-adjuvant chemotherapy by imaging
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 |
|---|---|---|
| Vacuum assisted biopsy (VAB)The trial intervention consists of a diagnostic interventional procedure, US-guided or mammographically guided VAB post-NAC, prior to the standard breast surgery. | Procedure or surgery | single arm |
Primary outcome
Sensitivity
Time frame: max. 6 weeks after registration
Sensitivity of I-VAB is defined as proportion of true positive patients (Both VAB and surgery showing non pCR) given patients with non pCR assessed using surgical specimen.
6 secondary outcomes
Specificity
Time frame: max. 6 weeks after registration
Positive predictive value (PPV)
Time frame: max. 6 weeks after registration
Negative predictive value (NPV)
Time frame: max. 6 weeks after registration
Accuracy (ACC)
Time frame: max. 6 weeks after registration
Surgical lymph node status
Time frame: max. 6 weeks after registration
Adverse events
Time frame: From US-guided VAB (max. 6 weeks after registration) until 2 weeks after breast surgery (max 1 day after VAB).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Christoph Tausch, MD study chair
Brust-Zentrum, Zürich
26 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vacuum assisted biopsy (VAB) in people with Breast Cancer, run by Klinik Hirslanden, Zurich at 26 sites in 4 countries.
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 9 inclusion and 8 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 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Switzerland, Germany, Austria, United Arab Emirates. 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 Daniel Tschopp (+41 44 387 9545, daniel.tschopp@hirslanden.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: max. 6 weeks after registration). 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 23 Oct 2024.