Cancer Screening for Ovarian Cancer

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: National Cancer Institute (NCI)

Disqualifiers: Cancer treatment, Prior cancer, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether certain screening tests can detect ovarian cancer early, potentially reducing mortality from this cancer. Participants will undergo ultrasound imaging (also known as ultrasonography) and provide blood samples to check for cancer markers. The trial is part of a larger study exploring screening methods for other cancers, such as prostate and lung. Women who have not had ovarian cancer or major surgeries on their colon or lungs and are not currently receiving cancer treatment might be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could lead to earlier detection and improved outcomes for ovarian cancer.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, it mentions that women taking Tamoxifen or Evista/Raloxifene are allowed to participate, so it seems some medications may be permitted.

What prior data suggests that these screening methods are safe for ovarian cancer detection?

Research has shown that transvaginal ultrasound (TVU), a type of imaging test, is safe and generally well-tolerated by patients. It is often used to screen for ovarian cancer due to its affordability and comfort for most individuals. Studies have found that TVU can reduce the risk of dying from ovarian cancer by 11% compared to not having the screening, as it helps detect cancer early and can potentially save lives.

TVU is considered a gentle procedure. It is non-invasive, meaning it doesn't involve surgery or deep penetration into the body. Most people experience little discomfort during the test. While some might find it slightly uncomfortable, serious side effects are rare.

Overall, TVU is a reliable and safe method for ovarian cancer screening. Discussing any concerns with a healthcare provider is important to ensure it is the right choice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the cancer screening techniques being studied for ovarian cancer because they aim to improve early detection, which is crucial for better outcomes. Unlike the traditional reliance on symptoms and occasional blood tests like the CA125, this approach combines ultrasonography and ultrasound imaging for a more comprehensive screening process. By potentially identifying ovarian cancer earlier, these methods could lead to earlier interventions and better survival rates. Additionally, the use of regular questionnaires helps track and identify cancer developments over time, providing valuable data beyond what standard care offers.

What evidence suggests that ultrasonography is effective for ovarian cancer screening?

Studies have shown that using ultrasound imaging to screen for ovarian cancer can greatly improve survival rates. In this trial, participants in the "Ovarian Screening" arm will undergo ultrasound screening. Specifically, research found that ultrasound screening reduced deaths from ovarian cancer by 11% compared to no screening. Women whose cancer was found through screening had a 20-year survival rate of 65%, double that of women who weren't screened. Additionally, the 5-year survival rate for those detected through screening was about 75%, significantly higher than the 54% for those not screened. This evidence suggests that ultrasound is a powerful tool for early detection of ovarian cancer, improving survival chances. ^{2 3 6 7 8}

Who Is on the Research Team?

Christine D Berg

Principal Investigator

National Cancer Institute (NCI)

Are You a Good Fit for This Trial?

This trial is for older individuals who may be at risk of ovarian cancer, including germ cell tumors. Participants should be willing to undergo screening tests like biomarker analysis and ultrasound imaging, as well as fill out health questionnaires.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Ovarian Screening

Participants undergo blood sample collection for CA125 analysis and transvaginal ultrasound (TVU) at baseline and annually for 3 years

3 years

Annual visits for 3 years

Follow-up

Participants are monitored for cancer incidence and mortality through annual updates for at least 13 years

13 years

Annual updates

What Are the Treatments Tested in This Trial?

Interventions

• Ultrasonography
• Ultrasound Imaging

Trial Overview The study is testing the effectiveness of various screening methods in diagnosing cancers early, specifically focusing on ovarian cancer. It's part of a larger effort that includes prostate, lung, colon, and rectal cancers.

How Is the Trial Designed?

Group I: Ovarian Screening Active Control 3 Interventions

Participants undergo blood sample collection for CA125 analysis at baseline annually for 5 years. Serum that is not used in the study will be stored in an NCI biorepository. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years. Participants complete a DQX at baseline and DHQ at year 3. An ADU (previously referred to as the PSH questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident cancers of the ovaries as all deaths that occur among both screened and control subjects during the trial.

Group II: Control Active Control 1 Intervention

Participants receive standard medical care. Participants complete a DHQ at baseline.

Ultrasonography is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Ultrasonography for:

• Diagnostic imaging for various conditions including breast cancer, liver diseases, kidney diseases, and musculoskeletal disorders

Approved in United States as Ultrasonography for:

• Diagnostic imaging for various conditions including breast cancer, liver diseases, kidney diseases, and musculoskeletal disorders

Approved in Canada as Ultrasonography for:

• Diagnostic imaging for various conditions including breast cancer, liver diseases, kidney diseases, and musculoskeletal disorders

Approved in Japan as Ultrasonography for:

• Diagnostic imaging for various conditions including breast cancer, liver diseases, kidney diseases, and musculoskeletal disorders

Approved in China as Ultrasonography for:

• Diagnostic imaging for various conditions including breast cancer, liver diseases, kidney diseases, and musculoskeletal disorders

Approved in Switzerland as Ultrasonography for:

• Diagnostic imaging for various conditions including breast cancer, liver diseases, kidney diseases, and musculoskeletal disorders

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study involving 23,188 abdominal examinations using the ultrasound contrast agent SonoVue, only 29 adverse events (AEs) were reported, indicating a very low incidence of complications.

The overall rate of serious adverse events was extremely low at 0.0086%, and SonoVue demonstrated a good safety profile, comparable to or better than other contrast agents used in radiology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of Sonovue in abdominal applications: retrospective analysis of 23188 investigations. Piscaglia, F., Bolondi, L.[2022]

The survey highlights current opinions on the safety of diagnostic ultrasound applications, indicating a need for ongoing evaluation of its safety profile.

The paper outlines specific labeling requirements for ultrasound equipment as proposed by the Netherlands' Committee on the Safety of Ultrasound, emphasizing the importance of clear communication regarding output levels and potential adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic ultrasound equipment. Safety and dosimetry. Thijssen, JM., van Beekum, WT., Daniëls, O., et al.[2005]

In a large retrospective analysis involving over 78,000 doses of ultrasound contrast agents (Definity and Optison), only 0.01% of patients experienced severe adverse reactions, indicating a strong safety profile for these agents.

The study found that severe reactions were primarily in outpatients, with no serious events reported in critically ill patients, suggesting that ultrasound contrast agents are safe for use in a variety of clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of deFinity and Optison for ultrasound image enhancement: a retrospective analysis of 78,383 administered contrast doses. Wei, K., Mulvagh, SL., Carson, L., et al.[2022]

In a study involving 34 pediatric patients with solid tumors, the intravenous administration of ultrasound contrast agents was found to be safe, with no significant changes in hemodynamic status observed during or after the procedure.

Only 2.2% of the procedures resulted in mild, transient side effects, such as taste alteration and tinnitus, which did not recur in subsequent examinations, indicating a favorable safety profile for these agents in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of ultrasound contrast agents in the pediatric oncologic population: a single-institution experience. Coleman, JL., Navid, F., Furman, WL., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6350495/

Ovarian cancer screening—ultrasound; impact on ... Analysis of the results showed that reduction of OC mortality by 15% with MMS and 11% with TVU, compared with no screening. These results are comparable to that ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3991859/

Ovarian cancer screening—Current status, future directions More encouraging data regarding survival was obtained from the Kentucky Screening Study, a single arm annual ultrasound screening study of 25,327 women [8].

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04473833

Transvaginal Ultrasonography As a Screening Method for ... The long-term survival (20 year) of women with screen-detected ovarian cancers is twice that of unscreened women (65% vs 32%). Separation of cases into Type 1 ...

4. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/full/10.1002/uog.17557

Screening for ovarian cancer: imaging challenges and ... Across all screen-detected invasive epithelial ovarian cancers, the mean ± SD 5-year survival rate was 74.8% ± 6.6% compared with 53.7% ± 2.3% ...

5. nature.com nature.com/articles/s41591-024-03329-4

International multicenter validation of AI-driven ultrasound ... Deep learning has shown promising results in the detection of ovarian cancer in ultrasound images; however, external validation is lacking.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5788737/

Screening for ovarian cancer: imaging challenges and ... TVU is an attractive screening modality because it is safe, cost effective, and well tolerated by patients. When included as part of a multimodal ovarian cancer ...

7. emedicine.medscape.com emedicine.medscape.com/article/255771-workup

Ovarian Cancer Workup Imaging studies used in ovarian cancer include ultrasonography ... screening tests for ovarian cancer screening: FDA Safety Communication.

8. mdpi.com mdpi.com/2075-4418/13/12/2078

Advantages and Limitations of Ultrasound as a Screening ... Data collected from 1187 postmenopausal women who underwent transvaginal ultrasound exams revealed that 17.2% of women had inadequate ultrasound ...