Breast NeoplasmsNCT01178736
Early Detection of Cancers in Low Resource Countries
An observational study of Breast Neoplasms and Uterine Cervical Neoplasms, run by Woman's Cancer Foundation at 3 sites in 3 countries.
Trial summary
The purpose of this study is to implement a community-based combined program for early detection of breast, cervical, ovarian and endometrial cancer in low-resource countries delivered through a free standing or a mobile Well Woman Clinic. Read more about this study
- Who is it for?
- Ages 30 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Neoplasms, Uterine Cervical Neoplasms, Ovarian Neoplasms
- What is being tested?
- Breast Cancer Screening and Diagnosis, Cervical Cancer Screening and Diagnosis and Ovarian Cancer Screening and Diagnosis
- Type of treatment
- Surgery or procedure
- How many people
- 36,000 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Mar 2011to Mar 2014
- 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 30 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Brazil has two rural hospitals serving a population of roughly 46,000 people (Nova Andradina) inside Mato Grosso do Sul, which has a population of over 2 million. Cambodia has a population of over 1 million inside the Phnom Penh metropolitan area. India has a population of more than 1.3 million inside the state of Goa. According to the NFHS-2, nearly 30 percent of rural Goan women live 10 or more kilometers away from a primary health center.
Who may be able to join
- Breast Cancer: women age 35-64
- Cervical Cancer: women age 30-59
- Ovarian Cancer: symptomatic post menopausal women age 50-64
- Endometrial Cancer: symptomatic post menopausal women age 50-64
Who cannot join
- women under the age of 30
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Brazil1 site
Hospital de Cancer de Barretos
São Paulo
Edmundo Mauad, MD, PhD, (17) 3321-6600, ecmauad@hcancerbarretos.com.br
Edmundo Mauad, MD, PhD
Cambodia1 site
Sihanouk Hospital Center of Hope, Hope Worldwide Cambodia
Phnom Penh
Cornelia Haener, MD, (855-23) 882-484, corneliahaener@sihosp.org
Shelly Malhotra, shellymalhotra@sihosp.org
India1 site
Manipal Healthcare Group
Goa
R.G. Pinto, MD, rgwpinto@gmail.com
Sharmila Sardesai, MD
About this study
Official title: Efficacy of a Combined Program for Early Detection of Breast and Gynecological Cancers in Low Resource Countries
The purpose of this study is to implement a community-based combined program for early detection of breast, cervical, ovarian and endometrial cancer in low-resource countries delivered through a free standing or a mobile Well Woman Clinic. The goals of this program are to downstage cancers and improve mortality rates using low-cost early detection methods. These programs will be implemented in regions where early cancer detection strategies are not in place and cancers present at advanced stages with resultant high mortality. Currently, there are three target project sites: Cambodia (June 2011), India (June 2011), and Brazil (March 2011). Memorandums of Understanding have been secured with local health organizations in each region to establish clinic operations. Each clinic would serve an approximate target population of 100,000 amongst whom about 12,000 eligible women (4-5,000 annually) will be invited to be screened for breast and cervical cancer over a three-year time span.
Read the detailed description
We will study the use of sonographic screening in addition to Clinical Breast Examination in low resource settings where screening programs are not currently in place and establishing a population based mammographic screening would be expensive, resource intensive, and difficult if not impossible to implement. The effectiveness of the screening and diagnostic methodology used for early detection of breast, cervical, ovarian and endometrial cancers in low resource settings will be studied. The program would involve screening of asymptomatic women for Breast and Cervical cancer and diagnostic assessment of symptomatic women for Ovarian and Endometrial cancer. Women in the age group of 30-59 yrs will be screened once every three years utilizing the following methods: Breast - clinical breast examination [CBE] and Sonography, followed by Fine needle aspiration biopsy (FNAB) of screen positive cases; Cervical - Human Papilloma Virus DNA testing followed by Cryotherapy of screen positive cases (Single visit, screen and treat approach); Ovarian - Transvaginal sonogram and clinical evaluation; Endometrial - Transvaginal sonographic assessment of the endometrial stripe.
- Being tested
- Breast Cancer Screening and Diagnosis, Cervical Cancer Screening and Diagnosis, Ovarian Cancer Screening and Diagnosis, Endometrial Cancer Screening and Diagnosis
- Keywords
- neoplasms
- Medical subject headings
- Breast Neoplasms, Uterine Cervical Neoplasms, Ovarian Neoplasms, Endometrial Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast Cancer Screening and DiagnosisProcedure or surgery
Also called FNAB, CBE, Ultrasound
Clinical Breast Examination and Sonography followed by Fine needle aspiration biopsy (FNAB) of screen positive cases.
Cervical Cancer Screening and DiagnosisProcedure or surgery
Also called HPV DNA
Visual Inspection with Acetic acid, PAP smear or Human Papilloma Virus DNA testing followed by Cryotherapy of screen positive cases.
Ovarian Cancer Screening and DiagnosisProcedure or surgery
Also called Ultrasound
Transvaginal sonogram and clinical evaluation in post menopausal women with symptoms suggestive of ovarian cancer.
Endometrial Cancer Screening and DiagnosisProcedure or surgery
Also called Ultrasound
Transvaginal sonographic assessment of the endometrial stripe in post menopausal women with abnormal bleeding.
| Study group | Role | What they receive |
|---|---|---|
| Cancer Screening and Diagnosis | Screening of asymptomatic women for Breast and Cervical cancer in the age group of 35-64 years. Diagnostic assessment of symptomatic women for Ovarian and Endometrial cancer in the age group of 50-64 years. Receives: Procedure: Breast Cancer Screening and Diagnosis; Procedure: Cervical Cancer Screening and Diagnosis; Procedure: Ovarian Cancer Screening and Diagnosis; Procedure: Endometrial Cancer Screening and Diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effectiveness of an Innovative, Low-Cost Screening and Diagnostic Methodology
This study will examine the effectiveness of an innovative, low-cost screening and diagnostic methodology used for combined early detection of breast and gynecological cancers in low resource regions where early cancer detection strategies are not in place and cancers currently are diagnosed at advanced stages with resultant high mortality.
Measured: Three (3) year interval
Secondary outcomes (1)
Effectiveness of CBE and Ultrasonography for Breast Cancer Detection
This study will examine the effectiveness of Clinical Breast Examination combined with Ultrasonography for breast cancer screening and detection in low resource settings where X-ray mammography proves not feasible in terms of cost, technology, and staff.
Measured: Three (3) year interval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2010 (estimated)
- Study startMar 2011
- Primary completionMar 2014 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 36,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Woman's Cancer Foundation
- Sponsor type
- University, hospital or other
- Investigators
- Weiwei Yang, MD, Principal investigator, M.D. Anderson Cancer Center, University of TexasDiljeet K Singh, MD, Principal investigator, Northwestern UniversityAdhemar Longatto Filho, MD, Principal investigator, University of Sao Paolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01178736
- Sponsor's protocol ID
- WCF-2011-BRA-IND-CAM
- Status last verified
- Aug 2010
- First submitted
- 6 Aug 2010
- Last updated
- 10 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Elmore JG, Armstrong K, Lehman CD, Fletcher SW. Screening for breast cancer. JAMA. 2005 Mar 9;293(10):1245-56. doi: 10.1001/jama.293.10.1245.
PubMed 15755947Kuhl CK. The "coming of age" of nonmammographic screening for breast cancer. JAMA. 2008 May 14;299(18):2203-5. doi: 10.1001/jama.299.18.2203. No abstract available.
PubMed 18477789Berg WA, Blume JD, Cormack JB, Mendelson EB, Lehrer D, Bohm-Velez M, Pisano ED, Jong RA, Evans WP, Morton MJ, Mahoney MC, Larsen LH, Barr RG, Farria DM, Marques HS, Boparai K; ACRIN 6666 Investigators. Combined screening with ultrasound and mammography vs mammography alone in women at elevated risk of breast cancer. JAMA. 2008 May 14;299(18):2151-63. doi: 10.1001/jama.299.18.2151.
PubMed 18477782Kolb TM, Lichy J, Newhouse JH. Comparison of the performance of screening mammography, physical examination, and breast US and evaluation of factors that influence them: an analysis of 27,825 patient evaluations. Radiology. 2002 Oct;225(1):165-75. doi: 10.1148/radiol.2251011667.
PubMed 12355001Kaplan SS. Clinical utility of bilateral whole-breast US in the evaluation of women with dense breast tissue. Radiology. 2001 Dec;221(3):641-9. doi: 10.1148/radiol.2213010364.
PubMed 11719658Tohno E, Ueno E, Watanabe H. Ultrasound screening of breast cancer. Breast Cancer. 2009;16(1):18-22. doi: 10.1007/s12282-008-0082-8. Epub 2008 Nov 14.
PubMed 19009372Sankaranarayanan R, Nene BM, Shastri SS, Jayant K, Muwonge R, Budukh AM, Hingmire S, Malvi SG, Thorat R, Kothari A, Chinoy R, Kelkar R, Kane S, Desai S, Keskar VR, Rajeshwarkar R, Panse N, Dinshaw KA. HPV screening for cervical cancer in rural India. N Engl J Med. 2009 Apr 2;360(14):1385-94. doi: 10.1056/NEJMoa0808516.
PubMed 19339719Schiffman M, Wacholder S. From India to the world--a better way to prevent cervical cancer. N Engl J Med. 2009 Apr 2;360(14):1453-5. doi: 10.1056/NEJMe0901167. No abstract available.
PubMed 19339726Goldie SJ, Kuhn L, Denny L, Pollack A, Wright TC. Policy analysis of cervical cancer screening strategies in low-resource settings: clinical benefits and cost-effectiveness. JAMA. 2001 Jun 27;285(24):3107-15. doi: 10.1001/jama.285.24.3107.
PubMed 11427139Goff BA, Mandel LS, Drescher CW, Urban N, Gough S, Schurman KM, Patras J, Mahony BS, Andersen MR. Development of an ovarian cancer symptom index: possibilities for earlier detection. Cancer. 2007 Jan 15;109(2):221-7. doi: 10.1002/cncr.22371.
PubMed 17154394Goff BA, Mandel LS, Melancon CH, Muntz HG. Frequency of symptoms of ovarian cancer in women presenting to primary care clinics. JAMA. 2004 Jun 9;291(22):2705-12. doi: 10.1001/jama.291.22.2705.
PubMed 15187051Menon U, Gentry-Maharaj A, Hallett R, Ryan A, Burnell M, Sharma A, Lewis S, Davies S, Philpott S, Lopes A, Godfrey K, Oram D, Herod J, Williamson K, Seif MW, Scott I, Mould T, Woolas R, Murdoch J, Dobbs S, Amso NN, Leeson S, Cruickshank D, McGuire A, Campbell S, Fallowfield L, Singh N, Dawnay A, Skates SJ, Parmar M, Jacobs I. Sensitivity and specificity of multimodal and ultrasound screening for ovarian cancer, and stage distribution of detected cancers: results of the prevalence screen of the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS). Lancet Oncol. 2009 Apr;10(4):327-40. doi: 10.1016/S1470-2045(09)70026-9. Epub 2009 Mar 11.
PubMed 19282241van Nagell JR Jr, DePriest PD, Ueland FR, DeSimone CP, Cooper AL, McDonald JM, Pavlik EJ, Kryscio RJ. Ovarian cancer screening with annual transvaginal sonography: findings of 25,000 women screened. Cancer. 2007 May 1;109(9):1887-96. doi: 10.1002/cncr.22594.
PubMed 17373668Van den Bosch T, Van Schoubroeck D, Domali E, Vergote I, Moerman P, Amant F, Timmerman D. A thin and regular endometrium on ultrasound is very unlikely in patients with endometrial malignancy. Ultrasound Obstet Gynecol. 2007 Jun;29(6):674-9. doi: 10.1002/uog.4031.
PubMed 17523157Smith-Bindman R, Kerlikowske K, Feldstein VA, Subak L, Scheidler J, Segal M, Brand R, Grady D. Endovaginal ultrasound to exclude endometrial cancer and other endometrial abnormalities. JAMA. 1998 Nov 4;280(17):1510-7. doi: 10.1001/jama.280.17.1510.
PubMed 9809732
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Combined Program for Early Detection of Breast and Gynecological Cancers in Low Resource Countries
- ClinicalTrials.gov ID
- NCT01178736
- Acronym / sponsor ID
- WCF-2011-BRA-IND-CAM
- Keywords
- neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 36,000 participants (estimated)
- Lead sponsor
- Woman's Cancer FoundationUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 10 Aug 2010 (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.
The purpose of this study is to implement a community-based combined program for early detection of breast, cervical, ovarian and endometrial cancer in low-resource countries delivered through a free standing or a mobile Well Woman Clinic. The goals of this program are to downstage cancers and improve mortality rates using low-cost early detection methods. These programs will be implemented in regions where early cancer detection strategies are not in place and cancers present at advanced stages with resultant high mortality. Currently, there are three target project sites: Cambodia (June 2011), India (June 2011), and Brazil (March 2011). Memorandums of Understanding have been secured with local health organizations in each region to establish clinic operations. Each clinic would serve an approximate target population of 100,000 amongst whom about 12,000 eligible women (4-5,000 annually) will be invited to be screened for breast and cervical cancer over a three-year time span.
Detailed description
We will study the use of sonographic screening in addition to Clinical Breast Examination in low resource settings where screening programs are not currently in place and establishing a population based mammographic screening would be expensive, resource intensive, and difficult if not impossible to implement. The effectiveness of the screening and diagnostic methodology used for early detection of breast, cervical, ovarian and endometrial cancers in low resource settings will be studied. The program would involve screening of asymptomatic women for Breast and Cervical cancer and diagnostic assessment of symptomatic women for Ovarian and Endometrial cancer. Women in the age group of 30-59 yrs will be screened once every three years utilizing the following methods: Breast - clinical breast examination [CBE] and Sonography, followed by Fine needle aspiration biopsy (FNAB) of screen positive cases; Cervical - Human Papilloma Virus DNA testing followed by Cryotherapy of screen positive cases (Single visit, screen and treat approach); Ovarian - Transvaginal sonogram and clinical evaluation; Endometrial - Transvaginal sonographic assessment of the endometrial stripe.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer Screening and Diagnosis | – | Procedure: Breast Cancer Screening and Diagnosis, Procedure: Cervical Cancer Screening and Diagnosis, Procedure: Ovarian Cancer Screening and Diagnosis, Procedure: Endometrial Cancer Screening and DiagnosisScreening of asymptomatic women for Breast and Cervical cancer in the age group of 35-64 years. Diagnostic assessment of symptomatic women for Ovarian and Endometrial cancer in the age group of 50-64 years. |
Who may qualify
- Ages
- 30 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Brazil has two rural hospitals serving a population of roughly 46,000 people (Nova Andradina) inside Mato Grosso do Sul, which has a population of over 2 million. Cambodia has a population of over 1 million inside the Phnom Penh metropolitan area. India has a population of more than 1.3 million inside the state of Goa. According to the NFHS-2, nearly 30 percent of rural Goan women live 10 or more kilometers away from a primary health center.
Key inclusion criteria (4 listed)
- Breast Cancer: women age 35-64
- Cervical Cancer: women age 30-59
- Ovarian Cancer: symptomatic post menopausal women age 50-64
- Endometrial Cancer: symptomatic post menopausal women age 50-64
Key exclusion criteria (1 listed)
- women under the age of 30
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 |
|---|---|---|
| Breast Cancer Screening and DiagnosisAlso: FNAB, CBE, UltrasoundClinical Breast Examination and Sonography followed by Fine needle aspiration biopsy (FNAB) of screen positive cases. | Procedure or surgery | Cancer Screening and Diagnosis |
| Cervical Cancer Screening and DiagnosisAlso: HPV DNAVisual Inspection with Acetic acid, PAP smear or Human Papilloma Virus DNA testing followed by Cryotherapy of screen positive cases. | Procedure or surgery | Cancer Screening and Diagnosis |
| Ovarian Cancer Screening and DiagnosisAlso: UltrasoundTransvaginal sonogram and clinical evaluation in post menopausal women with symptoms suggestive of ovarian cancer. | Procedure or surgery | Cancer Screening and Diagnosis |
| Endometrial Cancer Screening and DiagnosisAlso: UltrasoundTransvaginal sonographic assessment of the endometrial stripe in post menopausal women with abnormal bleeding. | Procedure or surgery | Cancer Screening and Diagnosis |
Primary outcome
The Effectiveness of an Innovative, Low-Cost Screening and Diagnostic Methodology
Time frame: Three (3) year interval
This study will examine the effectiveness of an innovative, low-cost screening and diagnostic methodology used for combined early detection of breast and gynecological cancers in low resource regions where early cancer detection strategies are not in place and cancers currently are diagnosed at advanced stages with resultant high mortality.
1 secondary outcome
Effectiveness of CBE and Ultrasonography for Breast Cancer Detection
Time frame: Three (3) year interval
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2010.
- Background: PubMed 15755947Elmore JG, Armstrong K, Lehman CD, Fletcher SW. Screening for breast cancer. JAMA. 2005 Mar 9;293(10):1245-56. doi: 10.1001/jama.293.10.1245.
- Background: PubMed 18477789Kuhl CK. The "coming of age" of nonmammographic screening for breast cancer. JAMA. 2008 May 14;299(18):2203-5. doi: 10.1001/jama.299.18.2203. No abstract available.
- Background: PubMed 18477782Berg WA, Blume JD, Cormack JB, Mendelson EB, Lehrer D, Bohm-Velez M, Pisano ED, Jong RA, Evans WP, Morton MJ, Mahoney MC, Larsen LH, Barr RG, Farria DM, Marques HS, Boparai K; ACRIN 6666 Investigators. Combined screening with ultrasound and mammography vs mammography alone in women at elevated risk of breast cancer. JAMA. 2008 May 14;299(18):2151-63. doi: 10.1001/jama.299.18.2151.
- Background: PubMed 12355001Kolb TM, Lichy J, Newhouse JH. Comparison of the performance of screening mammography, physical examination, and breast US and evaluation of factors that influence them: an analysis of 27,825 patient evaluations. Radiology. 2002 Oct;225(1):165-75. doi: 10.1148/radiol.2251011667.
- Background: PubMed 11719658Kaplan SS. Clinical utility of bilateral whole-breast US in the evaluation of women with dense breast tissue. Radiology. 2001 Dec;221(3):641-9. doi: 10.1148/radiol.2213010364.
- Background: PubMed 19009372Tohno E, Ueno E, Watanabe H. Ultrasound screening of breast cancer. Breast Cancer. 2009;16(1):18-22. doi: 10.1007/s12282-008-0082-8. Epub 2008 Nov 14.
- Background: PubMed 19339719Sankaranarayanan R, Nene BM, Shastri SS, Jayant K, Muwonge R, Budukh AM, Hingmire S, Malvi SG, Thorat R, Kothari A, Chinoy R, Kelkar R, Kane S, Desai S, Keskar VR, Rajeshwarkar R, Panse N, Dinshaw KA. HPV screening for cervical cancer in rural India. N Engl J Med. 2009 Apr 2;360(14):1385-94. doi: 10.1056/NEJMoa0808516.
- Background: PubMed 19339726Schiffman M, Wacholder S. From India to the world--a better way to prevent cervical cancer. N Engl J Med. 2009 Apr 2;360(14):1453-5. doi: 10.1056/NEJMe0901167. No abstract available.
- Background: PubMed 11427139Goldie SJ, Kuhn L, Denny L, Pollack A, Wright TC. Policy analysis of cervical cancer screening strategies in low-resource settings: clinical benefits and cost-effectiveness. JAMA. 2001 Jun 27;285(24):3107-15. doi: 10.1001/jama.285.24.3107.
- Background: PubMed 17154394Goff BA, Mandel LS, Drescher CW, Urban N, Gough S, Schurman KM, Patras J, Mahony BS, Andersen MR. Development of an ovarian cancer symptom index: possibilities for earlier detection. Cancer. 2007 Jan 15;109(2):221-7. doi: 10.1002/cncr.22371.
- Background: PubMed 15187051Goff BA, Mandel LS, Melancon CH, Muntz HG. Frequency of symptoms of ovarian cancer in women presenting to primary care clinics. JAMA. 2004 Jun 9;291(22):2705-12. doi: 10.1001/jama.291.22.2705.
- Background: PubMed 19282241Menon U, Gentry-Maharaj A, Hallett R, Ryan A, Burnell M, Sharma A, Lewis S, Davies S, Philpott S, Lopes A, Godfrey K, Oram D, Herod J, Williamson K, Seif MW, Scott I, Mould T, Woolas R, Murdoch J, Dobbs S, Amso NN, Leeson S, Cruickshank D, McGuire A, Campbell S, Fallowfield L, Singh N, Dawnay A, Skates SJ, Parmar M, Jacobs I. Sensitivity and specificity of multimodal and ultrasound screening for ovarian cancer, and stage distribution of detected cancers: results of the prevalence screen of the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS). Lancet Oncol. 2009 Apr;10(4):327-40. doi: 10.1016/S1470-2045(09)70026-9. Epub 2009 Mar 11.
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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.
Sihanouk Hospital Center of Hope, Hope Worldwide Cambodia
Phnom Penh, Cambodia
Weiwei Yang, MD principal investigator
M.D. Anderson Cancer Center, University of Texas
Diljeet K Singh, MD principal investigator
Northwestern University
Adhemar Longatto Filho, MD principal investigator
University of Sao Paolo
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms and Uterine Cervical Neoplasms, run by Woman's Cancer Foundation at 3 sites in 3 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 4 inclusion and 1 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 Aug 2010. 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 Brazil, Cambodia, India. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Effectiveness of an Innovative, Low-Cost Screening and Diagnostic Methodology (time frame: Three (3) year interval). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01178736, which also lists 17 linked publications.
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 Aug 2010.