Early Detection of Cancers in Low Resource Countries

NCT ID: NCT01178736

Last Updated: 2010-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

36000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2014-03-31

Brief Summary

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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

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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.

Conditions

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Breast Neoplasms Uterine Cervical Neoplasms Ovarian Neoplasms Endometrial Neoplasms

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Breast Cancer Screening and Diagnosis

Intervention Type PROCEDURE

Clinical Breast Examination and Sonography followed by Fine needle aspiration biopsy (FNAB) of screen positive cases.

Cervical Cancer Screening and Diagnosis

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Transvaginal sonogram and clinical evaluation in post menopausal women with symptoms suggestive of ovarian cancer.

Endometrial Cancer Screening and Diagnosis

Intervention Type PROCEDURE

Transvaginal sonographic assessment of the endometrial stripe in post menopausal women with abnormal bleeding.

Interventions

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Breast Cancer Screening and Diagnosis

Clinical Breast Examination and Sonography followed by Fine needle aspiration biopsy (FNAB) of screen positive cases.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Ovarian Cancer Screening and Diagnosis

Transvaginal sonogram and clinical evaluation in post menopausal women with symptoms suggestive of ovarian cancer.

Intervention Type PROCEDURE

Endometrial Cancer Screening and Diagnosis

Transvaginal sonographic assessment of the endometrial stripe in post menopausal women with abnormal bleeding.

Intervention Type PROCEDURE

Other Intervention Names

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FNAB CBE Ultrasound HPV DNA Ultrasound Ultrasound

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Woman's Cancer Foundation

OTHER

Sponsor Role lead

Responsible Party

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Woman's Cancer Foundation

Principal Investigators

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Weiwei Yang, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center, University of Texas

Diljeet K Singh, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University Feinberg School of Medicine

Adhemar Longatto Filho, MD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paolo

Locations

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Hospital de Cancer de Barretos

São Paulo, , Brazil

Site Status

Sihanouk Hospital Center of Hope, Hope Worldwide Cambodia

Phnom Penh, , Cambodia

Site Status

Manipal Healthcare Group

Goa, , India

Site Status

Countries

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Brazil Cambodia India

Facility Contacts

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Edmundo Mauad, MD, PhD

Role: primary

(17) 3321-6600

Cornelia Haener, MD

Role: primary

(855-23) 882-484

Shelly Malhotra

Role: backup

R.G. Pinto, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 15755947 (View on PubMed)

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.

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PMID: 18477789 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18477782 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12355001 (View on PubMed)

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.

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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.

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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.

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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.

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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.

Reference Type BACKGROUND
PMID: 17154394 (View on PubMed)

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.

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Reference Type BACKGROUND
PMID: 19282241 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17373668 (View on PubMed)

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.

Reference Type BACKGROUND
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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.

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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.

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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.

Reference Type BACKGROUND
PMID: 16084259 (View on PubMed)

Other Identifiers

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WCF-2011-BRA-IND-CAM

Identifier Type: -

Identifier Source: org_study_id

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