An observational study in Bone Neoplasms, Soft Tissue Neoplasms and Anxiety, sponsored by Istanbul University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by Istanbul University · Observational
This prospective observational study will follow adults who are scheduled for a clinically indicated biopsy because of a suspected solid tumor involving bone or soft tissue. The period before biopsy, the disclosure of pathology results, and the start of treatment may be associated with changing levels of psychological stress and anxiety.
The purpose of the study is to compare psychological stress and anxiety in the same participants at three points in their care: before biopsy, after the pathology result or diagnosis is explained, and at treatment initiation. The investigators hypothesize that psychological questionnaire scores will differ across these three time points and may be associated with age, sex, disease stage, metastasis status, and treatment type.
Participants will complete the Hospital Anxiety and Depression Scale, Perceived Stress Scale, and Distress Thermometer. The study team will also collect relevant demographic and routine clinical information from medical records. The study will not assign any biopsy, diagnostic procedure, or treatment. All diagnostic and treatment decisions will be made by the treating clinical team as part of routine care.
BIOPSY-STRESS is a single-center, prospective observational cohort study conducted at Istanbul University, Istanbul Faculty of Medicine, Department of Orthopedics and Traumatology, in collaboration with the Department of Psychiatry. Approximately 100 eligible adults who are scheduled for clinically indicated biopsy because of a suspected solid tumor will be recruited consecutively.
Psychological assessments will be performed at three prespecified stages of routine clinical care: before biopsy, after the pathology result or diagnosis has been communicated to the participant, and at treatment initiation. The assessments will include the Hospital Anxiety and Depression Scale, the Perceived Stress Scale, and the Distress Thermometer.
Relevant demographic, clinical, and radiological information will be obtained from routine hospital records, the hospital information management system, the picture archiving and communication system, and patient files. Prespecified clinical variables will include age, sex, disease stage or extent, metastasis status, and treatment type. No additional biopsy, imaging examination, laboratory test, or other invasive procedure will be performed for research purposes. The study will not assign participants to a diagnostic or therapeutic intervention.
The primary objective is to compare within-participant changes in psychological stress and anxiety levels across the pre-biopsy, post-diagnosis, and treatment-initiation assessments. The secondary objective is to identify demographic and clinical factors associated with higher psychological stress or anxiety.
Participant characteristics and questionnaire scores will be summarized using appropriate descriptive statistics. Change across the three assessment points will be evaluated using repeated-measures analysis of variance when the relevant assumptions are satisfied or the Friedman test when those assumptions are not satisfied. Where appropriate, multivariable linear regression or linear mixed-effects models will be used to examine associations between psychological outcomes and prespecified demographic and clinical factors. Effect estimates and 95% confidence intervals will be reported.
Study data will be collected prospectively and stored in coded form with access restricted to authorized study personnel. Participation involves only questionnaires and collection of routine clinical information. Possible research-related burdens include temporary emotional discomfort and fatigue while completing the questionnaires. Participants may pause questionnaire completion or withdraw from the study. Participants with marked anxiety or depressive symptoms, or those who report suicidal ideation, will be referred for same-day psychiatric evaluation in accordance with the study safety plan.
258 studies on the registry are indexed under Bone Neoplasms; 68 are open to participants now.
This study's planned enrollment of 100 is close to the median of 101 across 82 observational studies indexed under Bone Neoplasms.
Browse Bone Neoplasms studies →Istanbul University is the lead sponsor of 511 studies on the registry; 78 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adults receiving care in the Department of Orthopedics and Traumatology at Istanbul University, Istanbul Faculty of Medicine, who are scheduled for biopsy because of a suspected solid tumor. Consecutive eligible participants will be recruited into a single prospective cohort and followed from before biopsy through pathology-result disclosure and treatment initiation.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single prospective cohort of adults undergoing clinically indicated biopsy for a suspected solid tumor involving bone or soft tissue. Participants are assessed before biopsy, after pathology-result disclosure, and at treatment initiation. No diagnostic or therapeutic intervention is assigned by the study.
Other: Routine Diagnostic and Treatment Pathway
Observational exposure of interest. Participants undergo clinically indicated biopsy, pathology-result disclosure, and treatment initiation according to routine clinical care. The study does not assign biopsy, imaging, surgery, systemic treatment, radiotherapy, or any other treatment. Research activities consist of psychological questionnaires and collection of routine demographic, clinical, and radiologic data at the prespecified assessment points.
Hospital Anxiety and Depression Scale Anxiety Subscale Score Across Three Assessment Points
Participant-reported anxiety symptoms measured using the Hospital Anxiety and Depression Scale Anxiety subscale. Higher scores indicate greater anxiety symptom burden. Scores will be summarized at each assessment point, and within-participant differences across the three assessment points will be evaluated using prespecified repeated-measures methods.
Time frame: Within 7 days before biopsy; within 7 days after pathology-result disclosure; and within 7 days before or on the day of treatment initiation, before the first planned treatment.
Hospital Anxiety and Depression Scale Depression Subscale Score Across Three Assessment Points
Participant-reported depressive symptoms measured using the Hospital Anxiety and Depression Scale Depression subscale. Higher scores indicate greater depressive symptom burden. Scores will be summarized at each assessment point, and within-participant differences across the three assessment points will be evaluated using prespecified repeated-measures methods.
Time frame: Within 7 days before biopsy; within 7 days after pathology-result disclosure; and within 7 days before or on the day of treatment initiation, before the first planned treatment.
Perceived Stress Scale Total Score Across Three Assessment Points
Participant-reported perceived stress measured using the Perceived Stress Scale total score. Higher scores indicate greater perceived stress. Scores will be summarized at each assessment point, and within-participant differences across the three assessment points will be evaluated using prespecified repeated-measures methods.
Time frame: Within 7 days before biopsy; within 7 days after pathology-result disclosure; and within 7 days before or on the day of treatment initiation, before the first planned treatment.
Distress Thermometer Score Across Three Assessment Points
Global psychological distress measured using the Distress Thermometer, scored from 0 to 10. Higher scores indicate greater distress. Scores will be summarized at each assessment point, and within-participant differences across the three assessment points will be evaluated using prespecified repeated-measures methods.
Time frame: Within 7 days before biopsy; within 7 days after pathology-result disclosure; and within 7 days before or on the day of treatment initiation, before the first planned treatment.
Plan to share: No — Individual participant data will not be shared publicly or with external researchers. To safeguard participant confidentiality and comply with applicable ethical and legal data-protection requirements, including the Turkish Personal Data Protection Law (KVKK), study findings will be disseminated only in aggregate, non-identifiable form through peer-reviewed publications and scientific presentations.
Started Jul 2026 (actual). Primary completion is estimated for Dec 2026, 5 months after the start.
Of 37 observational studies under Bone Neoplasms, half reached primary completion within 192 months of starting (the median), counting those still running; a quarter within 41. This study's planned 5 months is below that.
How these figures are worked out, and which studies are left out of them.
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