Early Detection of Cancers in Low Resource Countries

Breast Neoplasms Clinical Trial

Official title:

Efficacy of a Combined Program for Early Detection of Breast and Gynecological Cancers in Low Resource Countries

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01178736
• Other study ID #: WCF-2011-BRA-IND-CAM
• Status: Not yet recruiting
• Phase: Phase 0
• First received: August 6, 2010
• Last updated: August 8, 2010
• Start date: March 2011
• Est. completion date: March 2014

Study information

• Verified date: August 2010
• Source: Woman's Cancer Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of HealthCambodia: Ministry of HealthIndia: Ministry of Health
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36000
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 64 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Neoplasms
• Endometrial Neoplasms
• Neoplasms
• Ovarian Neoplasms
• Uterine Cervical Neoplasms

Intervention

Procedure:
• Breast Cancer Screening and Diagnosis
Clinical Breast Examination and Sonography followed by Fine needle aspiration biopsy (FNAB) of screen positive cases.
• Cervical Cancer Screening and Diagnosis
Visual Inspection with Acetic acid, PAP smear or Human Papilloma Virus DNA testing followed by Cryotherapy of screen positive cases.
• Ovarian Cancer Screening and Diagnosis
Transvaginal sonogram and clinical evaluation in post menopausal women with symptoms suggestive of ovarian cancer.
• Endometrial Cancer Screening and Diagnosis
Transvaginal sonographic assessment of the endometrial stripe in post menopausal women with abnormal bleeding.

Locations

Country	Name	City	State
Brazil	Hospital de Cancer de Barretos	Sao Paolo
Cambodia	Sihanouk Hospital Center of Hope, Hope Worldwide Cambodia	Phnom Penh
India	Manipal Healthcare Group	Goa

Sponsors (1)

Lead Sponsor	Collaborator
Woman's Cancer Foundation

Countries where clinical trial is conducted

Brazil,  Cambodia,  India, 

References & Publications (17)

Amant F, Moerman P, Neven P, Timmerman D, Van Limbergen E, Vergote I. Endometrial cancer. Lancet. 2005 Aug 6-12;366(9484):491-505. Review. — View Citation

Berg WA, Blume JD, Cormack JB, Mendelson EB, Lehrer D, Böhm-Vélez 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. — View Citation

Elmore JG, Armstrong K, Lehman CD, Fletcher SW. Screening for breast cancer. JAMA. 2005 Mar 9;293(10):1245-56. Review. — View Citation

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. — View Citation

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. — View Citation

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. Erratum in: JAMA 2001 Sep 5;286(9):1026. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Three (3) year interval	No
Secondary	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.	Three (3) year interval	No