Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

cytology specimen collection procedure

annual screening

comparison of screening methods

James Mackay, MD, MA, FRCP, FRCPE

RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective treatment for ovarian cancer.

PURPOSE: Screening trial to determine the best procedure to detect ovarian cancer in women who have a high genetic risk for developing ovarian cancer.

OBJECTIVES:

* Determine an optimal screening procedure for ovarian cancer, in terms of the most appropriate screening test, criteria for interpretation of results, and screening intervals, in women at high genetic risk for developing ovarian cancer.
* Determine the physical morbidity and the resource implications associated with ovarian cancer screening in these women.
* Assess the feasibility of screening this high-risk population in terms of compliance rates.

OUTLINE: Patients undergo transvaginal ultrasonography of the ovaries (scheduled for the early follicular phase, day 3-6 of the menstrual cycle) and CA 125 measurement annually. Blood samples are collected every 4 months for analysis of CA 125 levels and novel markers.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 5,000 patients will be accrued for this study.

Screening Women at High Genetic Risk for Ovarian Cancer

The UK Familial Ovarian Cancer Screening Study

University College London Hospitals

screening questionnaire administration

Usha Menon, MBBS, MRCOG

RATIONALE: Screening tests may help doctors detect ovarian cancer early when the survival is much more encouraging. It is not yet known whether a CA125-based or ultrasound strategy is more effective in detecting ovarian cancer early thereby impacting on the mortality from the disease in postmenopausal women from the general population.

PURPOSE: Randomized clinical trial to assess the impact of screening using a multimodal strategy using CA125 interpreted by the Risk of Ovarian Cancer Algorithm (ROCA) followed by transvaginal ultrasound as a second line test versus transvaginal ultrasound on mortality from the disease in postmenopausal women from the general population.

OBJECTIVES:

* Determine the impact of preclinical detection of ovarian cancer by screening on ovarian cancer mortality in postmenopausal women.
* Determine the physical morbidity of ovarian cancer screening in this population.
* Determine the psychological consequences of screening results (true negative, true positive, false negative, and false positive) in this population.
* Compare the interventions that result from screening for ovarian cancer using CA 125 monitoring and ultrasound in this population.
* Compare the feasibility of population screening, in terms of compliance rates with annual screening for ovarian cancer with these strategies.
* Compare the performance of these screening strategies in this population.

OUTLINE: This is a randomized, multicenter study. Participants are randomized to 1 of 3 screening arms.

* Arm I: Participants do not undergo screening.
* Arm II: Participants undergo screening with an annual CA 125 level interpreted using the Risk of Ovarian Cancer Algorithm (ROCA). Depending on the results of the test, some patients may undergo additional screening.
* Arm III: Participants undergo screening with an annual transvaginal or transabdominal ultrasound. Depending on the results of the test, some patients may undergo additional screening.

Participants in all arms complete a health questionnaire at 3-5 years after study entry and in 2014.

PROJECTED ACCRUAL: A total of 200,000 participants (100,000 for arm I and 50,000 each for arms II and III) will be accrued for this study within 5 years.

202,638 participants randomised to: Multimodal Group: 50640 Ultrasound Group: 50639 Control Group: 101359

CA125 and Ultrasound in Detecting Ovarian Cancer in Postmenopausal Women

United Kingdom Collaborative Trial Of Ovarian Cancer Screening

Ovarian cancer diagnosis is based on outcomes review of medical notes of all women who developed ovarian cancer during the trial.

This is assessed through central medical note review and assigned by designated trial gynaecological oncologist.

Cost-effectivenesss of the multimodal (MMS) and ultrasound screening (USS) strategies separately comparing them to a no-screening arm: (a) Incremental cost-effectiveness analysis over the 14 year period of the trial (censorship 31st Dec 2014); (b) Incremental cost-effectiveness analysis for the cumulative mortality estimated over a 25-year period by extrapolating beyond the 14 years of the trial

National Institute for Health Research, United Kingdom

The Eve Appeal

Medical Research Council

Cancer Research UK

University College, London

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Herbal and Botanical

All Drugs and Chemicals

Cola

Participants undergo baseline screening colonoscopy

Participants undergo baseline screening colonoscopy. Participants are given individualized recommendations for further surveillance based on the results of the colonoscopy.

Participants undergo a baseline fecal occult blood test (FOBT). Participants are given individualized recommendations for further surveillance based on the results of the FOBT. Participants with negative baseline FOBT undergo FOBT annually for up to 4 years in the absence of a positive FOBT.

Participants with negative baseline FOBT undergo FOBT annually for up to 4 years in the absence of a positive FOBT

Participants undergo a baseline fecal occult blood test (FOBT)

fecal occult blood test

Patients undergo baseline screening colonoscopy

screening colonoscopy

standard follow-up care

Ann Zauber, PhD

RATIONALE: Screening tests, such as colonoscopy and fecal occult blood test, may help doctors find tumor cells early and plan better treatment for colorectal cancer.

PURPOSE: This randomized phase III trial is studying colonoscopy to see how well it works compared to fecal occult blood test in screening healthy participants for colorectal cancer.

OBJECTIVES:

* Compare the neoplastic outcome of participants at average risk for colorectal cancer who undergo colonoscopy vs annual fecal occult blood tests.
* Compare the endoscopic and clinical resources required for these screening methods in these participants.
* Compare the benefit-to-harm ratio in participants undergoing these screening methods.
* Determine the level of participation of participants undergoing these screening methods.

OUTLINE: This is a randomized, two-part, multicenter study.

Participants are asked whether they are interested in participating in a randomized controlled trial of colorectal cancer screening.

* Screening colonoscopy feasibility study I (accrual completed as of 12/14/2004): Participants who are interested in participating in a screening trial are randomized to 1 of 2 screening arms.

  * Arm I: Participants undergo baseline screening colonoscopy.
  * Arm II: Participants receive standard care.
* Screening colonoscopy feasibility study II: Participants who are interested in participating in a screening trial are randomized to 1 of 2 screening arms.

  * Arm I: Participants undergo baseline screening colonoscopy. Participants are given individualized recommendations for further surveillance based on the results of the colonoscopy.
  * Arm II: Participants undergo a baseline fecal occult blood test (FOBT). Participants are given individualized recommendations for further surveillance based on the results of the FOBT. Participants with negative baseline FOBT undergo FOBT annually for up to 4 years in the absence of a positive FOBT.

All participants are followed annually for up to 4 years.

PROJECTED ACCRUAL: A total of 1,402 participants (701 per screening arm) have been accrued for feasibility study I within 3 years (accrual completed as of 12/14/2004). An additional 3,550 participants (1,775 per screening arm) will be accrued for feasibility study II within 5 years.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Screening Women at High Genetic Risk for Ovarian Cancer	NCT00033488	Ovarian Cancer	cytology specim... annual screenin... comparison of s...	35 Years -	National Cancer Institute (NCI)
CA125 and Ultrasound in Detecting Ovarian Cancer in Postmenopausal Women	NCT00058032	Ovarian Cancer	screening quest... annual screenin...	50 Years - 74 Years	University College, London
Colonoscopy or Fecal Occult Blood Test in Screening Healthy Participants for Colorectal Cancer	NCT00102011	Colorectal Canc...	annual screenin... fecal occult bl... screening colon... standard follow...	40 Years - 69 Years	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for annual screening