International Registry for Men With Advanced Prostate Cancer (IRONMAN) (IRONMAN)

May 19, 2026 updated by: Prostate Cancer Clinical Trials Consortium

Our intent is to establish the International Registry to Improve Outcomes in Men with Advanced Prostate Cancer (IRONMAN) as a prospective, international cohort of minimum 5,000 men with advanced cancer, including men with mHSPC and M0/M1 CRPC. The goal is to establish a population-based registry and recruit patients across academic and community practices from Australia, Barbados, Brazil, Canada, Ireland, Jamaica, Kenya, Nigeria, Norway, Spain, South Africa, Sweden, Switzerland, the United Kingdom (UK), and the United States (US). Target accrual number and number of participating sites are subject to change based on accrual, funding, and interest in participation by other international sites. This cohort study will facilitate a better understanding of the variation in care and treatment of advanced prostate cancer across countries and across academia and community based practices.

Detailed data will be collected from patients at study enrollment and then during follow-up, for a minimum of five years. Patients will be followed prospectively for overall survival, clinically significant adverse events, comorbidities, changes in cancer treatments, and PROMs.

PROMs questionnaires will be collected at enrollment and every three months thereafter.

Physician Questionnaires will be collected from all participating sites at patient enrollment, time of first change in treatment and/or one year follow-up, at each subsequent change of treatment, and discontinuation of treatment.

As such, this registry will help identify the treatment sequences or combinations that optimize overall survival and PROMs for men with mHSPC and M0/M1 CRPC. By collecting blood at enrollment, time of first change in treatment and/or one year follow-up (plasma, cell free DNA, buffy coat / RNA), this registry will further identify and validate molecular phenotypes of disease that predict response and resistance to specific therapeutics. Additionally, every effort will be made to collect blood specimen at each subsequent change in treatment due to progression of disease. When feasible, existing tumor tissue may be collected for correlation with described blood based studies. All samples will be used for future research. This cohort study will provide the research community with a unique biorepository to identify biomarkers of treatment response and resistance.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

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

Study Contact

Study Locations

  • Australia
      • Melbourne, Australia
        • Recruiting
        • Australian Urology Associates
        • Contact:
          • Mark Frydenberg
        • Principal Investigator:
          • Mark Frydenberg
      • Melbourne N., Australia
        • Recruiting
        • Australian Prostate Centre
        • Contact:
        • Principal Investigator:
          • Philip Dundee, MD
    • Brisbane
      • Herston, Brisbane, Australia
        • Recruiting
        • Royal Brisbane & Women's Hospital
        • Contact:
        • Principal Investigator:
          • Ian D Davis, MD
    • New South Wales
      • Darlinghurst, New South Wales, Australia
        • Recruiting
        • St. Vincent's Hospital Sydney
        • Contact:
        • Principal Investigator:
          • Anthony Joshua, MD
      • Sydney, New South Wales, Australia
        • Recruiting
        • Westmead Hospital
        • Principal Investigator:
          • Howard Gurney
        • Contact:
          • Howard Gurney
      • Sydney, New South Wales, Australia
        • Recruiting
        • Macquarie University
        • Principal Investigator:
          • Howard Gurney
        • Contact:
          • Howard Gurney
    • Queensland
      • Cleveland, Queensland, Australia
        • Recruiting
        • Redland Hospital
        • Contact:
          • Ian Vela
        • Principal Investigator:
          • Ian Vela
      • Woolloongabba, Queensland, Australia
        • Recruiting
        • Princess Alexandra Hospital
        • Contact:
          • Ian Vela
        • Principal Investigator:
          • Ian Vela
    • Victoria
      • Box Hill, Victoria, Australia
        • Recruiting
        • Eastern Health (Box Hill Hospital)
        • Contact:
          • Ian Davis
        • Principal Investigator:
          • Ian Davis
      • Melbourne, Victoria, Australia, 3000
        • Recruiting
        • Peter MacCallum Cancer Centre
        • Contact:
        • Principal Investigator:
          • Declan Murphy
      • Mount Waverley, Victoria, Australia, 3149
        • Recruiting
        • Epworth Healthcare
        • Contact:
        • Principal Investigator:
          • Ben Tran, MD
  • Barbados
      • Bridgetown, Barbados
        • Recruiting
        • The University of the West Indies - Cave Hill Campus
        • Contact:
        • Principal Investigator:
          • Simon Anderson, MBBCh
  • Brazil
      • Curitiba, Brazil
        • Completed
        • Instituto do Câncer e Transplante
      • Porto Alegre, Brazil
        • Active, not recruiting
        • Centro de Pesquisa em Oncologia
      • São Paulo, Brazil
        • Completed
        • Instituto Câncer do Estado de São Paulo
      • São Paulo, Brazil
        • Completed
        • Centro Paulista de Oncologia
    • Rio Grande do Sul
      • Bento Gonçalves, Rio Grande do Sul, Brazil, 95700-084
        • Active, not recruiting
        • Tacchini Hospital
    • São Paulo
      • Bela Vista, São Paulo, Brazil
        • Terminated
        • Hospital Beneficência Portuguesa
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Recruiting
        • Cross Cancer Institute (Alberta Health Services)
        • Contact:
        • Principal Investigator:
          • Michael Kolinsky, MD
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Recruiting
        • BC Cancer Agency
        • Contact:
          • Kim Chi
        • Principal Investigator:
          • Kim Chi
    • Ontario
      • Hamilton, Ontario, Canada
        • Recruiting
        • Juravinski Cancer Centre
        • Contact:
          • Sebastian Hotte
        • Principal Investigator:
          • Sebastian Hotte
      • Ottawa, Ontario, Canada
        • Recruiting
        • Ottawa Hospital Cancer Centre
        • Principal Investigator:
          • Michael Ong
        • Contact:
          • Michael Ong
      • Toronto, Ontario, Canada, M5G 2C1
        • Recruiting
        • Princess Margaret Cancer Centre
        • Contact:
        • Principal Investigator:
          • Antonio Finelli, MD
    • Quebec
      • Montreal, Quebec, Canada
        • Recruiting
        • Centre Hospitalier de l'Universite de Montreal (CHUM)
        • Contact:
          • Fred Saad
        • Principal Investigator:
          • Fred Saad
      • Québec, Quebec, Canada
        • Recruiting
        • CHU de Quebec-Universite Laval
        • Principal Investigator:
          • Frédéric Pouliot
        • Contact:
          • Frederic Pouliot
  • Ireland
      • Dublin, Ireland, D24 NR0A
        • Recruiting
        • Tallaght University Hospital
        • Contact:
        • Principal Investigator:
          • Ray McDermott, MD
      • Dublin, Ireland
        • Recruiting
        • St. Vincent's University Hospital
        • Contact:
        • Principal Investigator:
          • Ray McDermott, MD
      • Sligo, Ireland, F91 H684
        • Recruiting
        • Sligo University Hospital
        • Contact:
        • Principal Investigator:
          • Ala Yousif, MD
    • Leinster
      • Dublin, Leinster, Ireland
        • Recruiting
        • Beacon Hospital
        • Contact:
          • Ray McDermott
        • Principal Investigator:
          • Ray McDermott
  • Jamaica
      • Kingston, Jamaica
        • Recruiting
        • The University of the West Indies - Mona Campus
        • Contact:
        • Principal Investigator:
          • Simone Badal, PhD
  • Kenya
      • Nairobi, Kenya
        • Recruiting
        • University of Nairobi
        • Contact:
        • Principal Investigator:
          • Charles G Waihenya, MBChB
  • Nigeria
      • Abeokuta, Nigeria
        • Active, not recruiting
        • Federal Medical Centre Abeokuta
      • Ilorin, Nigeria
        • Active, not recruiting
        • University of Ilorin Teaching Hospital
      • Lagos, Nigeria
        • Active, not recruiting
        • Lagos State University Teaching Hospital
      • Maiduguri, Nigeria
        • Active, not recruiting
        • University of Maiduguri Teaching Hospital
  • Norway
      • Oslo, Norway, 0379
        • Recruiting
        • Oslo University Hospital
        • Contact:
        • Principal Investigator:
          • Kjell Russnes, MD
  • South Africa
      • Cape Town, South Africa, 7925
        • Active, not recruiting
        • Groote Schuur Hospital
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2196
        • Active, not recruiting
        • The Medical Oncology Centre of Rosebank
      • Pretoria, Gauteng, South Africa, 0084
        • Active, not recruiting
        • Steve Biko Academic Hospital
  • Spain
      • Badalona, Spain
        • Active, not recruiting
        • Institut Català d'Oncologia Badalona
      • Barcelona, Spain
        • Active, not recruiting
        • Fundació Institut Mar d'Investigacions Mèdiques (Hospital del Mar).
      • Castellon, Spain
        • Active, not recruiting
        • Hospital Provincial de Castellon
      • Madrid, Spain, 28006
        • Active, not recruiting
        • Hospital Universitario La Princesa
      • Madrid, Spain
        • Active, not recruiting
        • Hospital Clinico San Carlos
      • Madrid, Spain
        • Active, not recruiting
        • Hospital Universitario 12 de octubre
      • Oviedo, Spain, 33011
        • Active, not recruiting
        • Hospital Universitario Central de Asturias
      • Zaragoza, Spain
        • Active, not recruiting
        • Hospital Universitario Miguel Servet (Zaragoza)
    • Barcelona
      • Barcelona, Barcelona, Spain
        • Active, not recruiting
        • Hospital Clínic de Barcelona
    • Catalonia
      • Barcelona, Catalonia, Spain
        • Active, not recruiting
        • Vall d'Hebron Institute of Oncology
    • Málaga
      • Málaga, Málaga, Spain
        • Active, not recruiting
        • Hospital Universitario Virgen de la Victoria
    • Valencia
      • Valencia, Valencia, Spain, 46009
        • Active, not recruiting
        • Instituto Valenciano de Oncologia
  • Sweden
    • Skåne County
      • Malmö, Skåne County, Sweden
        • Recruiting
        • Skåne University Hospital
        • Contact:
          • Anders Bjartell
        • Principal Investigator:
          • Anders Bjartell
    • Sweden
      • Umeå, Sweden, Sweden, 907 37
        • Recruiting
        • Umea University Hospital
        • Contact:
        • Principal Investigator:
          • Camilla karlsson, MD
  • Switzerland
      • Basel, Switzerland
        • Active, not recruiting
        • Universitätsspital Basel
      • Chur, Switzerland
        • Active, not recruiting
        • Kantonsspital Graubunden
      • Sankt Gallen, Switzerland
        • Active, not recruiting
        • Kantonsspital St. Gallen
      • Zurich, Switzerland, 8039
        • Active, not recruiting
        • Onkozentrum Zürich
      • Zurich, Switzerland
        • Active, not recruiting
        • UniversitätsSpital Zürich
    • Bellinzona
      • Bellinzona, Bellinzona, Switzerland, 6500
        • Active, not recruiting
        • Ente Ospedaliero Cantonale
  • United Kingdom
      • Cardiff, United Kingdom
        • Recruiting
        • Velindre Cancer Centre
        • Contact:
        • Principal Investigator:
          • Jacob Tanguay, MD
      • Lancaster, United Kingdom
        • Recruiting
        • University Hospitals of Morecambe Bay NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Alison Birtle, MD
      • London, United Kingdom
        • Recruiting
        • Guys St Thomas NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Deborah Enting
      • London, United Kingdom
        • Recruiting
        • The Royal Marsden NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Vincent Khoo, MD
      • Manchester, United Kingdom
      • Metropolitan Borough of Wirral, United Kingdom
        • Recruiting
        • Clatterbridge Cancer Centre
        • Contact:
        • Principal Investigator:
          • Isabel Syndikus, MD
      • Preston, United Kingdom, PR2 9HT
        • Recruiting
        • Lancashire Teaching Hospitals NHS Foundation Trust
        • Principal Investigator:
          • Alison Birtle, MD
        • Contact:
      • Sheffield, United Kingdom, S10 2SB
        • Recruiting
        • Sheffield Teaching Hospitals NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Carmel Pezaro, MD
      • South Shields, United Kingdom, NE34 0PL
        • Terminated
        • South Tyneside District Hospital
      • Sunderland, United Kingdom, SR4 7TP
        • Terminated
        • Sunderland Royal Hospital
    • Hampshire
      • Southampton, Hampshire, United Kingdom
        • Recruiting
        • University Hospital Southampton NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Simon Crabb, MD
    • Hertfordshire
      • Stevenage, Hertfordshire, United Kingdom, SG1 4AB
        • Recruiting
        • Lister Hospital
        • Contact:
        • Principal Investigator:
          • Anand Sharma, MD
    • Middlesex
      • Northwood, Middlesex, United Kingdom, HA6 2RN
        • Recruiting
        • Mount Vernon Cancer Centre
        • Contact:
        • Principal Investigator:
          • Anand Sharma, MD
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Completed
        • University of Alabama-Birmingham
      • Tuscaloosa, Alabama, United States, 35487
        • Recruiting
        • University of Alabama- Tuscaloosa
        • Contact:
        • Principal Investigator:
          • Camille Ragin, PhD
    • California
      • Los Angeles, California, United States, 90024
        • Terminated
        • University of California - Los Angeles
      • San Diego, California, United States, 92037
        • Recruiting
        • University of California San Diego
        • Principal Investigator:
          • Rana McKay, MD
        • Contact:
          • Rana McKay, MD
    • Connecticut
      • New Haven, Connecticut, United States, 06502
        • Recruiting
        • Yale University
        • Principal Investigator:
          • Daniel Petrylak, MD
        • Contact:
    • Florida
      • Gainesville, Florida, United States, 32611
        • Terminated
        • University of Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic Jacksonville
        • Contact:
        • Principal Investigator:
          • Folakemi Odedina, PhD
      • Tampa, Florida, United States, 33612
    • Georgia
      • Atlanta, Georgia, United States, 30310
        • Recruiting
        • Morehouse School of Medicine
        • Contact:
        • Principal Investigator:
          • James Lillard, PhD
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory Winship Cancer Institute
        • Principal Investigator:
          • Mehmet Bilen, MD
        • Contact:
          • Mehmet Bilen, MD
    • Illinois
      • Chicago, Illinois, United States, 60637
      • Chicago, Illinois, United States, 60607
        • Recruiting
        • University of Illinois at Chicago
        • Contact:
        • Principal Investigator:
          • Daniel Moreira, MD
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Robert H. Lurie Comprehensive Cancer Center of Northwestern University
        • Contact:
        • Principal Investigator:
          • David Vanderweele, MD
      • DeKalb, Illinois, United States, 60115
        • Recruiting
        • Kishwaukee Cancer Center
        • Contact:
        • Principal Investigator:
          • Christopher George, MD
      • Geneva, Illinois, United States, 60134
        • Recruiting
        • Delnor Cancer Center
        • Contact:
        • Principal Investigator:
          • Christopher George, MD
      • Warrenville, Illinois, United States, 60555
        • Recruiting
        • Warrenville Cancer Center
        • Contact:
        • Principal Investigator:
          • Christopher George, MD
    • Louisiana
      • New Orleans, Louisiana, United States, 70118
        • Active, not recruiting
        • Tulane University
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Recruiting
        • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
        • Contact:
      • Towson, Maryland, United States, 21204
        • Terminated
        • Chesapeake Urology Associates
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
      • Worcester, Massachusetts, United States, 01655
        • Recruiting
        • University of Massachusetts Memorial Medical Center
        • Contact:
          • Kriti Mittal, MD
        • Principal Investigator:
          • Kriti Mittal, MD
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Terminated
        • University of Michigan
      • Detroit, Michigan, United States, 48201
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Recruiting
        • University of Mississippi Medical Center
        • Contact:
        • Principal Investigator:
          • John Henegan, MD
    • New York
      • Brooklyn, New York, United States, 11215
        • Recruiting
        • NewYork-Presbyterian Brooklyn Methodist Hospital
        • Principal Investigator:
          • Scott Tagawa, MD
        • Contact:
      • Buffalo, New York, United States, 14203
        • Active, not recruiting
        • Roswell Park Comprehensive Cancer Center
      • Buffalo, New York, United States, 14215
        • Terminated
        • VA Western New York Healthcare System
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center
        • Principal Investigator:
          • Mark Stein, MD
        • Contact:
          • Mark Stein, MD
      • New York, New York, United States, 10065
        • Recruiting
        • Weill Cornell Medical Center
        • Principal Investigator:
          • Scott Tagawa, MD
        • Contact:
          • Scott Tagawa, MD
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
      • Durham, North Carolina, United States, 27710
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Durham VA Medical Center
        • Contact:
        • Principal Investigator:
          • Rhonda Bitting, MD
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke Cancer Network
        • Principal Investigator:
          • Tian Zhang, MD
        • Contact:
          • Tian Zhang, MD
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Cleveland Medical Center
        • Principal Investigator:
          • Pedro Barata, MD
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University Hospital
        • Contact:
        • Principal Investigator:
          • Sokolova
    • Pennsylvania
      • Doylestown, Pennsylvania, United States, 18901
        • Completed
        • Doylestown Health
      • Philadelphia, Pennsylvania, United States, 19134
        • Recruiting
        • Fox Chase Cancer Center - Temple Health
        • Principal Investigator:
          • Camille Ragin, PhD
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19107
        • Active, not recruiting
        • Thomas Jefferson University
      • West Reading, Pennsylvania, United States, 19611
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Recruiting
        • Ralph H. Johnson VA Medical Center
        • Contact:
        • Principal Investigator:
          • Stephen Savage, MD
      • Columbia, South Carolina, United States, 29209
        • Terminated
        • William Jennings Bryan Dorn VAMC
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Recruiting
        • Baptist Clinical Research Institute
        • Contact:
        • Principal Investigator:
          • Osarenren Ogbeide, MD
      • Memphis, Tennessee, United States, 38104
        • Recruiting
        • Memphis VA Medical Center
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
        • Completed
        • Baylor College of Medicine
    • Virginia
    • Washington
      • Seattle, Washington, United States, 98195
        • Active, not recruiting
        • University of Washington Medical Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • Recruiting
        • University of Wisconsin Carbone Cancer Center
        • Principal Investigator:
          • Hamid Emamekhoo, MD
        • Contact:
          • Hamid Emamekhoo, MD

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Metastatic hormone sensitive prostate cancer (mHSPC): Prostate cancer patients diagnosed with histologically confirmed cancer with radiological evidence of metastatic disease and on ADT for no more than 90 days.

Castration resistant prostate cancer (CRPC): Prostate cancer patients (with or without radiological evidence of metastatic disease) with a confirmed rising PSA (at least two measures) while on ADT or orchiectomy or castrate level of testosterone as determined by investigator.

Prostate cancer patients with mixed histological types may participate in this Registry.

Description

• Willing and able to provide written informed consent and privacy authorization for the release of personal health information.

NOTE: Privacy authorization may be either included in the informed consent or obtained separately.

  • Males 21 years of age and above
  • Histological or cytological confirmed prostate adenocarcinoma from TRUS biopsy, radical prostatectomy or TURP Or Documented histopathology or cytopathology of prostate adenocarcinoma from a biopsy of a metastatic site Or Metastatic disease typical of prostate cancer (i.e., involving bone or pelvic lymph nodes or para-aortic lymph nodes) AND a serum concentration of PSA >20ng/mL at the time of initial prostate cancer diagnosis
  • No previous diagnosis of a second, non-prostate malignancy that requires additional systemic therapy except cancer in situ of bladder and basal cell cancer of skin

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Castrate Resistant Prostate Cancer
Other: Standard of Care
Drugs routinely administered for metastatic prostate cancer per local standard.
Hormone Sensitive Prostate Cancer
Other: Standard of Care
Drugs routinely administered for metastatic prostate cancer per local standard.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Practice Patterns
Time Frame: 5 years
To describe the practice patterns of therapeutic agents for treatment of advanced prostate cancer internationally
5 years

Collaborators and Investigators

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

Sponsor

Prostate Cancer Clinical Trials Consortium

Investigators

  • Principal Investigator: Daniel George, MD, Duke Cancer Institute
  • Principal Investigator: Lorelei Mucci, ScD, Harvard School of Public Health (HSPH)
  • Principal Investigator: Phillip Kantoff, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

July 21, 2017

Primary Completion (Estimated)

January 1, 2031

Study Completion (Estimated)

January 1, 2032

Study Registration Dates

First Submitted

May 10, 2017

First Submitted That Met QC Criteria

May 11, 2017

First Posted (Actual)

May 12, 2017

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • c16-170

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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