Ultrasound-guided Tru-cut Biopsy in Patients with Suspected Ovarian Cancer: Adequacy, Accuracy, Safety and Patient Assessment.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity Hospital Hradec Kralove

About this trial

The goal of this prospective observational study is to evaluate the role of ultrasound-guided tru-cut biopsy (in the hands of an expert certified sonographer within a gynecological center)in patients with suspected ovarian cancer.

The main questions it aims to answer are:

Is the material from tru-cut biopsy adequate for histopathological and immunohistochemical examination? Is the material accurate in comparison with the final pathological specimen? What are the patient experience and complications after the procedure?

Participants who will undergo a standard tru-cut biopsy procedure will need to additionally answer the questionnaire.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

suspected advanced ovarian cancer

indication for tru-cut biopsy by multidisciplinary oncoboard

Disqualifiers

patient deny to undergo tru-cut biopsy

Trial population

Patients with suspected advanced ovarian cancer

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Adequacy of tru-cut biopsy in ovarian cancer

Evaluation of the adequacy of the procedure in diagnosing ovarian cancer by histopathological and immunohistochemical examination.

Time frame
From the tru-cut biopsy to the histopathological result.

Secondary outcomes

1

Accuracy of tru-cut biopsy in ovarian cancer

Evaluation of accuracy between tru-cut biopsy and definitive histology in ovarian cancer.

Time frame
From the tru-cut biopsy to the definitive histopathological examination from the surgery.

Other outcomes

1

Patient assesment

To evaluate the patient experience with tru-cut biopsy and to record complications.

Time frame
From the tru-cut biopsy to the first follow-up visit.

Sponsors and contacts

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