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Liquid Biopsies for Improving the Pre-operative Diagnosis of Ovarian Cancer

NCT04971421UNKNOWNOBSERVATIONAL

Summary

An accurate preoperative diagnosis of an ovarian tumor is important for the patients' surgical work-up, proper referral to oncological centers and for the patients' mental wellbeing since uncertainty about the nature (benign vs malignant) of an ovarian tumor may cause anxiety. Currently, the Risk of Malignancy Index (RMI), with a cut-off value of 200, is often used in the Netherlands to select patients with an increased risk of ovarian cancer that should be referred to an oncologic center. However sensitivity and specificity of the RMI-score are far from optimal. Around 40% of the referred patients have benign disease in final pathological examination. Therefore, other models have been developed, such as the IOTA (International Ovarian Tumor Analysis) consortium algorithms, but these models require training, expertise and are subjective. To determine the nature of an ovarian tumor, histological examination is the golden standard. However, a pre-operative biopsy of an ovarian tumor is undesirable because of the risk of spill of tumor cells in the abdominal cavity. Therefore, there is an urgent need for non-invasive diagnostic tools to determine the nature of an ovarian tumor pre-operatively. Liquid biopsies could be such a non-invasive tool. Currently, circulating tumor DNA (ctDNA) circulating tumor cells (CTC), microRNA (miRNA) and tumor-educated platelets (TEPs) are available and can function as a potential blood-based biosource for (early) cancer diagnostics. Previous studies show promising results of liquid biopsies are used in (early) detection of cancer, also for ovarian cancer. Therefore, a diagnostic algorithm will be developed using ct-DNA and TEPs as liquid biomarkers in combination with the existing ultrasound models (RMI and IOTA-models) and tumor markers (CA125 and HE4) to differentiate between early ovarian cancer and benign ovarian tumors pre-operatively. Nature and extent of the burden and risks associated with participation, benefit and group relatedness. There is no extra burden/risk for the patients in this study. Five extra vials of blood will be collected from each participant and two questionnaires will be filled out.

Key Facts

Lead Sponsor

The Netherlands Cancer Institute

Enrollment

450

Start Date

2021-04-14

Completion Date

2024-08-01

Study Type

OBSERVATIONAL

Official Title

OVI-DETECT Liquid Biopsies for Improving the Pre-operative Diagnosis of Ovarian Cancer

Interventions

ctDNA - circulating tumor DNATEP - Tumor Educated Platelets

Conditions

Ovarian Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria:

1. Age ≥18 years
2. Presence of a ovarian tumor and referred to specialized center for surgery based on:

   1. Any ultrasound model e.g. RMI-scoring model ; IOTA-rules
   2. Subjective assessment of the referring gynecologist
   3. Normal Glomerular Filtration Rate (GFR): \>60ml/min/1,73m2
3. General criteria: a. Understanding of Dutch language b. Fit for surgery (WHO 1-2) c. Written informed consent

Exclusion Criteria:

1. Suspicion of advanced-stage of disease, e.g. ascites or peritoneal depositions
2. History of cancer (excl. BCC) within 5 years prior to inclusion
3. Multiple malignancies at the same time

Outcome Measures

Primary Outcomes

The diagnostic accuracy of the developed algorithm

The diagnostic accuracy of the developed algorithm, displayed as sensitivity and specificity.

Time frame: 3 -4 years

Secondary Outcomes

Cost-effective analysis (I)

The cost effectiveness of the algorithm in the differentiation between (early) OC and benign ovarian tumors will be measured by using different validated questionnaires. The EQ-5D-5L questionnaire will be used to measure cost-effectiveness modeling, QoL will be measured by means of utilities in order to derive quality adjusted life-years (QALYs). The utilities will reflect the preferences of society for length of life versus quality of life.

Time frame: 3 -4 years

Cost-effective analysis (II)

The (Dutch) Medical Consumption Questionnaire (iMCQ) includes questions related to frequently occurring contacts with health care providers. The costs of medical consumption are calculated by multiplying the measured volumes of care by the cost price per unit of care. The higher the score more medical consumption is used.

Time frame: 3 -4 years

Cost-effective analysis (III)

The (Dutch) Productivity Cost Questionnaire (iPCQ) will be used to measure the impact of disease on the ability of a person to perform work, either employed or unemployed. It is divided into 3 categories: 1. absences of work measured in days from 0 to 28 days or more, either employed or unemployed; 2. the cost of productivity loss for participants and the employees will be calculated by the friction cost method and the human capital method. Higher scores mean more production loss, for employed participants; 3. The cost of productivity loss from unpaid work is calculated by multiplying the amount of productivity loss by a standard hourly rate of household care. Higher scores mean more production loss, for unemployed participants;

Time frame: 3 -4 years

Psychological Burden (I)

The EQ-5D will be used to measure within five different domains the health status of the patient before and after the surgical intervention and between different ovarian tumor origins. For example a health status can be better, worse or the same. The self-reported visual scale standard, which is part of the EQ-5D, with a value of 80.6 is scored as a normal value for healthy individuals.

Time frame: 3 -4 years

Psychological Burden (II)

The EORTC-QLQ-C30 will be used to measure cancer specific cancer-specific quality-of-life, using 5 functional scales, 3 symptom scales, a global health status/quality of life scale, and a number of single items assessing additional symptoms (dyspnea, sleep disturbance, constipation and diarrhea) and perceived financial impact. For ease of presentation and interpretation, all subscale and individual item responses are linearly converted to a 0 to 100 scale. For the functional and global quality of life scales, a higher score represents a better level of functioning. For the symptom scales and items, a higher score reflects a greater degree of symptoms. Individual item responses are linearly converted to a 0 to 100 scale. The EORTC QLQ-OV28 a 4-point Likert-type response scale is used, ranging from "not at all" to "very much. Results from patients with a benign and malignant ovarian tumor will be compared in the assessment of quality of life.

Time frame: 3 -4 years

Psychological Burden (III)

The EORTC QLQ-OV28 a 4-point Likert-type response scale is used, ranging from "not at all" to "very much. Results from patients with a benign and malignant ovarian tumor will be compared in the assessment of quality of life.

Time frame: 3 -4 years

Psychological Burden (IV)

The Cancer Worry Scale will be used to assess the worries among the included patients for having ovarian cancer. For all items of the Cancer Worry Scale a 4-point Likert-type response scale is used, ranging from "not at all" to "very much".

Time frame: 3 -4 years

Psychological Burden (V)

The Intolerance of Uncertainty Scale (Dutch version IUS-12), will be used to measures both anxious and avoidance components of intolerance of uncertainty. For this study it will be used to measure the coping patients have when faced uncertainty before the final diagnosis is known. It makes use of on 5-point Likert-type response scale is used, ranging from "very strongly disagree" to "very strongly agree".

Time frame: 3 -4 years

Psychological Burden (VI)

Decision of regret scale is a 5-point scale to measure the "distress or remorse after a (health) care decision". Participants will be asked to reflect on a specific past decision, and then will be asked to indicate the extent to which they agree or disagree on the regret scale by indicating a number from 1 (Strongly Agree) to 5 (Strongly Disagree) that best indicates their level of agreement. The amount of regret is measured at a point of time when the participant can reflect on the effects of the decision. This scale will be used to measure the regret patients could have on being referred to an oncological center, independently of the final origin of tumor.

Time frame: 3 -4 years

Locations

Dutch Cancer Institute NKI-AVL, Amsterdam, Netherlands

Amsterdam UMC loc VUmc, Amsterdam-Zuidoost, Netherlands

Catharina hospital Eindhoven, Eindhoven, Netherlands

Leiden University Medical Center, Leiden, Netherlands

Linked Diseases

Ovarian Neoplasms

Ovarian Neoplasms — a type of gynecological cancer.