Validation of Ovarian Adnexal Mass Assessment Score Test System

This study is testing a scoring system that calculates how likely it is that a mass (lump) is malignant (cancerous). Researchers want to find out if the system is better than current clinical practice for predicting malignancy.

The study will enroll patients who have an ovarian cyst or adnexal mass (a lump in the uterus) that requires surgery. A blood sample will be collected from each participant before surgery. Researchers will apply the scoring system to the sample and compare it with the patient’s post-surgery diagnosis (cancerous vs. not cancerous).

Sponsored by

Patrocinado por

Gesponsert von

Gesponsert von

Opdrachtgever:

Cleo Diagnostics

Participants

Participantes

Teilnehmenden

Deelnemers:

1000

People

Personen

Participate by

Participar mediante

Abschlussdatum

Uiterlijke Inschrijving:

June 30, 2025

30.6.2025

30.6.2025

30.6.2025

Who is the study for? 

Females aged 18 and above who:

  • Have an ovarian cyst or adnexal mass identified through imaging examination (transvaginal ultrasound - TVU) that requires surgery, but have not yet undergone this surgery
  • Have not been diagnosed with ovarian cancer with or without treatment for ovarian cancer
  • Have not had both ovaries removed 
  • Do not have a prior history of gynecological malignancy (cancer) within last 2 years  
  • Do not have a prior history of melanoma (within last 2 years)
  • Do not have prior treatment (within 12 months of sample collection) with chemotherapy, radiotherapy, or immunotherapy 
  • Are not pregnant and have not been pregnant in the last 3 months 
  • Are not immune-compromised. Examples:some text
    • Immune-suppressive conditions (e.g. HIV/AIDS)
    • Patients undergoing immunotherapy, chemotherapy, or radiation (within the last 12 months) for any reason
    • Patients receiving immune suppressive therapies (e.g. transplant recipients, individuals with known autoimmune disease)
    • Patients who have a primary immunodeficiency disorder (e.g. Lupus)

What is expected of me? 

  1. You will fill out a questionnaire on this website to determine your eligibility.
  2. If you are eligible based on the questionnaire, the study team will contact you. If necessary, they will ask you to sign an authorization form so they can view medical records related to this study.
  3. If you are eligible based on the questionnaire and your records, they will contact you to schedule an on-site study appointment.
  4. At the study appointment, you will review & sign informed consent, fill out a health information questionnaire, and have 1 tube of blood drawn. The appointment will last up to 1 hour.

What is the benefit for me?

You will receive $50 compensation for completing the on-site study appointment.

Validation of Ovarian Adnexal Mass Assessment Score Test System

This study is testing a scoring system that calculates how likely it is that a mass (lump) is malignant (cancerous). Researchers want to find out if the system is better than current clinical practice for predicting malignancy.

The study will enroll patients who have an ovarian cyst or adnexal mass (a lump in the uterus) that requires surgery. A blood sample will be collected from each participant before surgery. Researchers will apply the scoring system to the sample and compare it with the patient’s post-surgery diagnosis (cancerous vs. not cancerous).

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Study for

Estudio dirigido a

Zielgrupper der Studie

Onderzoek voor:

Female adults who have an ovarian cyst or adnexal mass identified that requires surgery, but who have NOT YET undergone this surgery.

Sponsored by

Patrocinado por

Gesponsert von

Opdrachtgever:

Cleo Diagnostics

Participants

Participantes

Teilnehmenden

Deelnemers:

1000

People

Personen

Participate by

Participar mediante

Abschlussdatum

Duur van onderzoek:

June 30, 2025

30.6.2025

30.6.2025

30.6.2025

Who is the study for? 

¿A quién va dirigido el estudio?

Für wen ist die Studie geeignet?

Voor wie is het onderzoek bedoeld?

Females aged 18 and above who:

  • Have an ovarian cyst or adnexal mass identified through imaging examination (transvaginal ultrasound - TVU) that requires surgery, but have not yet undergone this surgery
  • Have not been diagnosed with ovarian cancer with or without treatment for ovarian cancer
  • Have not had both ovaries removed 
  • Do not have a prior history of gynecological malignancy (cancer) within last 2 years  
  • Do not have a prior history of melanoma (within last 2 years)
  • Do not have prior treatment (within 12 months of sample collection) with chemotherapy, radiotherapy, or immunotherapy 
  • Are not pregnant and have not been pregnant in the last 3 months 
  • Are not immune-compromised. Examples:some text
    • Immune-suppressive conditions (e.g. HIV/AIDS)
    • Patients undergoing immunotherapy, chemotherapy, or radiation (within the last 12 months) for any reason
    • Patients receiving immune suppressive therapies (e.g. transplant recipients, individuals with known autoimmune disease)
    • Patients who have a primary immunodeficiency disorder (e.g. Lupus)

What is expected of me? 

¿Qué se espera de mí?

Was wird von mir erwartet?

Wat wordt van mij verwacht?

  1. You will fill out a questionnaire on this website to determine your eligibility.
  2. If you are eligible based on the questionnaire, the study team will contact you. If necessary, they will ask you to sign an authorization form so they can view medical records related to this study.
  3. If you are eligible based on the questionnaire and your records, they will contact you to schedule an on-site study appointment.
  4. At the study appointment, you will review & sign informed consent, fill out a health information questionnaire, and have 1 tube of blood drawn. The appointment will last up to 1 hour.
Contact our study team

What is the benefit for me?

¿En qué me beneficia?

Welchen Nutzen habe ich davon?

Wat is het voordeel voor mij?

You will receive $50 compensation for completing the on-site study appointment.

Complete this questionnaire to take part.

Fülle diesen Fragebogen aus, um herauszufinden, ob Du berechtigt bist