78216 Participants Needed

Cancer Screening for Ovarian Cancer

Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: National Cancer Institute (NCI)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

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.12345

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 CA125.678910

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.6781112

Who Is on the Research Team?

CD

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?
2Treatment groups
Active Control
Group I: Ovarian ScreeningActive Control3 Interventions
Group II: ControlActive Control1 Intervention

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

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Approved in European Union as Ultrasonography for:
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Approved in United States as Ultrasonography for:
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Approved in Canada as Ultrasonography for:
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Approved in Japan as Ultrasonography for:
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Approved in China as Ultrasonography for:
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Approved in Switzerland as Ultrasonography for:

Find a Clinic Near You

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.
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.
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.
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]

Citations

Ovarian Cancer Screening Falls Short. [2022]
Performance of ultrasound as a second line test to serum CA125 in ovarian cancer screening. [2022]
Performance of ultrasound as a second line test to serum CA125 in ovarian cancer screening. [2022]
Ultrasound and ovarian cancer screening: is there a future? [2022]
Early detection of ovarian tumors using ultrasound. [2016]
The safety of Sonovue in abdominal applications: retrospective analysis of 23188 investigations. [2022]
Diagnostic ultrasound equipment. Safety and dosimetry. [2005]
[Potential bioeffects in interaction between ultrasound and tissue--safety of diagnostic ultrasound]. [2013]
The safety of deFinity and Optison for ultrasound image enhancement: a retrospective analysis of 78,383 administered contrast doses. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Safety of ultrasound contrast agents in the pediatric oncologic population: a single-institution experience. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
The current status of ultrasound and color Doppler imaging in screening for ovarian cancer. [2016]
12.United Statespubmed.ncbi.nlm.nih.gov
Ultrasound and ovarian cancer. [2019]
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