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Trial registered on ANZCTR


Registration number
ACTRN12624000882527
Ethics application status
Approved
Date submitted
25/06/2024
Date registered
19/07/2024
Date last updated
19/07/2024
Date data sharing statement initially provided
19/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A Diagnostic Test to Evaluate Cancer Risk Before Surgery in Women With an Ovarian Mass
Scientific title
Validation of an Ovarian Adnexal Mass Assessment Score Test System in Women With an Ovarian Mass
Secondary ID [1] 312401 0
CT-2023-CTN-05057-1
Universal Trial Number (UTN)
U1111-1309-8397
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ovarian cancer 334210 0
adnexal mass 334211 0
benign ovarian mass 334212 0
Condition category
Condition code
Cancer 330875 330875 0 0
Ovarian and primary peritoneal
Reproductive Health and Childbirth 330877 330877 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study will benchmark the performance of the CleoDX Pre-Surgical triage Test against the use of CA125&transvaginal ultrasound to predict risk of malignancy prior to surgery in patients with an adnexal mass. Patients provide a single serum sample prior to surgical referral, in addition to that provided for standard-of-care tests. There is no patient follow-up required.

The CleoDX Pre-Surgical Test measures a combination of 5 biomarkers in serum (CA125, HE4, IL6, active CXCL10 and total CXCL10) from patients, and combines the result into a single score (from 1-10) as an indicator of malignancy risk. It is used to assist in the pre-surgical determination of likelihood that an adnexal mass may be malignant, and ensure triage to an appropriate surgical expertise for further evaluation.

The test will be indicated for use in patients in whom the presence of an adnexal mass requires surgical intervention, but who have not yet been seen by an oncologist. Typically these patients will have received ultrasound imaging and CA125 test, and the results of the test indicate referral to a surgeon for secondary evaluation is warranted.
Intervention code [1] 328905 0
Diagnosis / Prognosis
Intervention code [2] 328906 0
Early Detection / Screening
Comparator / control treatment
As per standard of care, patients with a suspected adnexal mass undergo (i) transvaginal ultrasound and (ii) CA125 serum testing. These two standard tests are used to assist in determining the risk of malignancy, and refer patients to an appropriate secondary evaluation for surgical intervention. This testing occurs in a general clinical setting for every patient prior to referral.

This trial will access a single serum sample from patients who have already received standard of care testing, and are being referred for surgical evaluation. The serum sample will be accessed from a single blood draw provided at the time of referral, processed through a standard pathology provider network and then stored until sufficient numbers for batch analysis are obtained.

The result of serum testing using the CleoDX test will be retrospectively correlated with pathology findings, and its ability to pre-surgically differentiate benign from malignant masses compared to the initial indication obtained using standard-of-care CA125 and transvaginal ultrasound.

There is no intervention arising as a result of the test findings. The study is purely observational.
Control group
Active

Outcomes
Primary outcome [1] 338631 0
Calculation of a CleoDX Pre-Surgical Triage Test malignancy risk score
Timepoint [1] 338631 0
Scores will be determined retrospectively on completion of study enrollment (anticipated maximum 1 year following surgery).
Secondary outcome [1] 437159 0
Diagnostic sensitivity of CleoDX Pre-Surgical Triage Test malignancy risk score to identify cancer patients
Timepoint [1] 437159 0
Blood samples will be collected at enrollment prior to surgery.. Ultrasound reports and CA125 serum titre will be collected as they become available, which may occur before or after surgery. Any pathology findings will be collected after surgery and histopathological examination of any tissue removed.
Secondary outcome [2] 437684 0
Diagnostic specificity of CleoDX Pre-Surgical Triage Test malignancy risk score to identify cancer patients
Timepoint [2] 437684 0
Blood samples will be collected at enrollment prior to surgery.. Ultrasound reports and CA125 serum titre will be collected as they become available, which may occur before or after surgery. Any pathology findings will be collected after surgery and histopathological examination of any tissue removed.

Eligibility
Key inclusion criteria
1. Female patients => 18 years of age at the time of consent
2. Can provide written informed consent
3. Have an ovarian cyst or adnexal mass (simple, complex, or solid ovarian/pelvic mass) identified through imaging examination (transvaginal ultrasound - TVU) that requires surgery, but have not yet undergone surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnant currently / within the last 3 months
2. Current or previous ovarian cancer
3. Prior bilateral oophorectomy or otherwise in surgical menopause
4. Diagnosed with any gynecological malignancy within last 2 years
5. Diagnosed with melanoma within last 2 years
6. Current or prior (previous 12 months) treatment with chemotherapy, radiotherapy or immunotherapy
7. Immune-compromised – defined as those whose weakened immune system may render them more susceptible to infection, illness, or complications. These may include patients with immune-suppressive conditions (e.g. HIV/AIDS), patients undergoing immuno-, chemo- or radio-therapy (within the last 12 months) for any reason, receiving immune suppressive therapies (e.g. transplant recipients, individuals with known autoimmune disease), or with a primary immunodeficiency disorder (e.g. Lupus).

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/07/2024
Actual
Date of last participant enrolment
Anticipated
30/04/2026
Actual
Date of last data collection
Anticipated
31/07/2026
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26726 0
Monash Medical Centre - Moorabbin campus - East Bentleigh
Recruitment hospital [2] 26728 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 42773 0
3165 - East Bentleigh
Recruitment postcode(s) [2] 42775 0
3168 - Clayton
Recruitment outside Australia
Country [1] 26396 0
United States of America
State/province [1] 26396 0

Funding & Sponsors
Funding source category [1] 316809 0
Commercial sector/Industry
Name [1] 316809 0
Cleo Diagnostics Ltd
Country [1] 316809 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Cleo Diagnostics Ltd
Address
Country
Australia
Secondary sponsor category [1] 319038 0
None
Name [1] 319038 0
Address [1] 319038 0
Country [1] 319038 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315580 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 315580 0
Ethics committee country [1] 315580 0
Australia
Date submitted for ethics approval [1] 315580 0
07/12/2023
Approval date [1] 315580 0
03/04/2024
Ethics approval number [1] 315580 0
HREC/103505/MonH-2023-402747(v1)

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135142 0
Prof Tom Jobling
Address 135142 0
c/o Monash Health Gynecological Oncology Unit 823-865 Centre Rd, Bentleigh East VIC 3165
Country 135142 0
Australia
Phone 135142 0
+613 9928 8243
Fax 135142 0
Email 135142 0
[email protected]
Contact person for public queries
Name 135143 0
Leona Chan
Address 135143 0
c/o Hudson Institute of Medical Research, Level 3, 27-31 Wright St Clayton 3168
Country 135143 0
Australia
Phone 135143 0
+613 8572 2686
Fax 135143 0
Email 135143 0
[email protected]
Contact person for scientific queries
Name 135144 0
Andrew Stephens
Address 135144 0
c/o Hudson Institute of Medical Research, Level 3, 27-31 Wright St Clayton 3168
Country 135144 0
Australia
Phone 135144 0
+613 8572 2686
Fax 135144 0
Email 135144 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.