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

78216 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial studies whether screening methods used to diagnose cancer of the prostate, lung, colon, rectum, or ovaries can reduce deaths from these cancers. Screening tests may help doctors find cancer cells early and plan better treatment for ovarian cancer. The ovarian cancer screening tests are part of a trial that addresses the screening of four cancer sites, each with their own results record: prostate (NCT00002540), lung (NCT01696968), colorectal (NCT01696981), and ovarian (NCT01696994).

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 data supports the effectiveness of the treatment Ultrasonography for ovarian cancer screening?

Research shows that while ultrasound can detect early ovarian changes, large studies have not found it reduces death rates from ovarian cancer. Some trials, like the Kentucky trial, reported a shift to detecting cancer at earlier stages, which could improve survival, but overall, the benefit in reducing mortality is not clear. ^{1 2 3 4 5}

Is ultrasound imaging safe for humans?

Ultrasound imaging is generally considered safe for humans. A large study of over 23,000 cases using an ultrasound contrast agent found very few adverse events, with only two serious cases, indicating a good safety profile. Additionally, there is no evidence of harmful effects in fetuses, and safety measures are in place to ensure responsible use. ^{6 7 8 9 10}

How is ultrasound imaging used in ovarian cancer screening different from other treatments?

Ultrasound imaging is unique in ovarian cancer screening because it helps detect changes in the ovaries' structure and blood flow, which can indicate cancer. Unlike other treatments, it is non-invasive and can identify early-stage cancers, although it is more effective in high-risk groups and often used alongside other tests like serum CA125. ^{2 3 4 11 12}

Research Team

Christine D Berg

Principal Investigator

National Cancer Institute (NCI)

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Ovarian Cancer Screening Falls Short. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Performance of ultrasound as a second line test to serum CA125 in ovarian cancer screening. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Performance of ultrasound as a second line test to serum CA125 in ovarian cancer screening. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Ultrasound and ovarian cancer screening: is there a future? [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Early detection of ovarian tumors using ultrasound. [2016]

6. England pubmed.ncbi.nlm.nih.gov

The safety of Sonovue in abdominal applications: retrospective analysis of 23188 investigations. [2022]

7. Ireland pubmed.ncbi.nlm.nih.gov

Diagnostic ultrasound equipment. Safety and dosimetry. [2005]

8. Bulgaria pubmed.ncbi.nlm.nih.gov

[Potential bioeffects in interaction between ultrasound and tissue--safety of diagnostic ultrasound]. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

The safety of deFinity and Optison for ultrasound image enhancement: a retrospective analysis of 78,383 administered contrast doses. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Safety of ultrasound contrast agents in the pediatric oncologic population: a single-institution experience. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

The current status of ultrasound and color Doppler imaging in screening for ovarian cancer. [2016]

12. United States pubmed.ncbi.nlm.nih.gov

Ultrasound and ovarian cancer. [2019]