Validation of Ovarian Adnexal Mass Assessment Score Test System

This research 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 research 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).

This is a research study only - the test results will not be shared with you or your doctors and will not influence your medical care.

Study target:

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

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:

March 31, 2026

31.3.2026

31.3.2026

31.3.2026

Who is the study for? 

Females aged 18 and above who:

  • Have an ovarian cyst or adnexal mass identified through radiological imaging (i.e. Ultrasound, MRI, CT Scan) 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 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 complete an optional eligibility questionnaire on this website or contact the study team directly to express interest in participating.
  2. Provide medical records authorization so the study team can review records related to your ovarian/pelvic mass to confirm eligibility.
  3. If you are eligible based on the questionnaire and your records, you will attend one clinic visit (approximately 1 hour) that includes informed consent, health information questionnaire and have 1 tube of blood drawn.
  4. After your surgery, the study team will collect your surgical results from your medical records to compare with your blood test.

What is the benefit for me?

You will receive compensation for your participation - the study team will provide specific details about the amount and travel reimbursement when they contact you.

What are the risks?

Validation of Ovarian Adnexal Mass Assessment Score Test System

This research 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 research 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).

This is a research study only - the test results will not be shared with you or your doctors and will not influence your medical care.

Study target:

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

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Haga clic aquí para participar
Teilnehmen
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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 through radiological imaging, that requires surgery, but 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:

March 31, 2026

31.3.2026

31.3.2026

31.3.2026

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 radiological imaging (i.e. Ultrasound, MRI, CT Scan) 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 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 complete an optional eligibility questionnaire on this website or contact the study team directly to express interest in participating.
  2. Provide medical records authorization so the study team can review records related to your ovarian/pelvic mass to confirm eligibility.
  3. If you are eligible based on the questionnaire and your records, you will attend one clinic visit (approximately 1 hour) that includes informed consent, health information questionnaire and have 1 tube of blood drawn.
  4. After your surgery, the study team will collect your surgical results from your medical records to compare with your blood test.
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 compensation for your participation - the study team will provide specific details about the amount and travel reimbursement when they contact you.

Complete this questionnaire to take part.

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