Early Detection of Cancers in Low Resource Countries
8 augustus 2010 bijgewerkt door: Woman's Cancer Foundation
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.
Studie Overzicht
Toestand
Onbekend
Conditie
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Verwacht)
36000
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
30 jaar tot 64 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Vrouw
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
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.
Beschrijving
Inclusion Criteria:
- 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
Exclusion Criteria:
- women under the age of 30
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
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.
|
Clinical Breast Examination and Sonography followed by Fine needle aspiration biopsy (FNAB) of screen positive cases.
Andere namen:
Visual Inspection with Acetic acid, PAP smear or Human Papilloma Virus DNA testing followed by Cryotherapy of screen positive cases.
Andere namen:
Transvaginal sonogram and clinical evaluation in post menopausal women with symptoms suggestive of ovarian cancer.
Andere namen:
Transvaginal sonographic assessment of the endometrial stripe in post menopausal women with abnormal bleeding.
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
The Effectiveness of an Innovative, Low-Cost Screening and Diagnostic Methodology
Tijdsspanne: 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.
|
Three (3) year interval
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Effectiveness of CBE and Ultrasonography for Breast Cancer Detection
Tijdsspanne: Three (3) year interval
|
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.
|
Three (3) year interval
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Weiwei Yang, MD, M.D. Anderson Cancer Center, University of Texas
- Hoofdonderzoeker: Diljeet K Singh, MD, Northwestern University Feinberg School of Medicine
- Hoofdonderzoeker: Adhemar Longatto Filho, MD, University of Sao Paolo
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Kolb 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.
- Kaplan 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.
- Berg 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. Erratum In: JAMA. 2010 Apr 21;303(15):1482.
- Sankaranarayanan 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.
- Goff 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.
- 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.
- Smith-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.
- Kuhl 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.
- Tohno 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.
- Schiffman 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.
- Goldie 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. Erratum In: JAMA 2001 Sep 5;286(9):1026.
- Goff 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.
- Menon 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.
- van 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.
- Van 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.
- Tabor A, Watt HC, Wald NJ. Endometrial thickness as a test for endometrial cancer in women with postmenopausal vaginal bleeding. Obstet Gynecol. 2002 Apr;99(4):663-70. doi: 10.1016/s0029-7844(01)01771-9.
- Amant F, Moerman P, Neven P, Timmerman D, Van Limbergen E, Vergote I. Endometrial cancer. Lancet. 2005 Aug 6-12;366(9484):491-505. doi: 10.1016/S0140-6736(05)67063-8.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 maart 2011
Primaire voltooiing (Verwacht)
1 maart 2014
Studie voltooiing (Verwacht)
1 maart 2014
Studieregistratiedata
Eerst ingediend
6 augustus 2010
Eerst ingediend dat voldeed aan de QC-criteria
8 augustus 2010
Eerst geplaatst (Schatting)
10 augustus 2010
Updates van studierecords
Laatste update geplaatst (Schatting)
10 augustus 2010
Laatste update ingediend die voldeed aan QC-criteria
8 augustus 2010
Laatst geverifieerd
1 augustus 2010
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Huidziektes
- Urogenitale neoplasmata
- Neoplasmata per site
- Baarmoeder Neoplasmata
- Genitale neoplasmata, vrouwelijk
- Baarmoederhalsaandoeningen
- Baarmoeder Ziekten
- Endocriene systeemziekten
- Ovariële ziekten
- Adnexale ziekten
- Gonadale aandoeningen
- Endocriene klierneoplasmata
- Borst ziekten
- Neoplasmata
- Baarmoeder Cervicale Neoplasmata
- Borstneoplasmata
- Ovariumneoplasmata
- Endometriumneoplasmata
Andere studie-ID-nummers
- WCF-2011-BRA-IND-CAM
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