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Danish Vulva Cancer Recurrence Study

NCT06495554RecruitingNAINTERVENTIONAL

Summary

The overall aim is to investigate different aspects of recurrence detection in women with vulva cancer (VC) to identify optimal treatment- and surveillance programs. DaVulvaRec is a Danish nationwide multicenter study with patient inclusion from Aarhus University Hospital and Rigshospitalet, Denmark. Applying a mixed method research design, the investigators will collect and analyze patient-reported outcome measures in combination with procedural data to evaluate symptomatology and map actions taken during the patient's pathway from primary disease to recurrence. Furthermore, the investigators aim to examine if circulating tumor-DNA (ctDNA) can be detected in liquid biopsies from VC patients. All patients will be followed for two years or until recurrence. Patient-reported outcome measures will be completed every four months during surveillance, and liquid biopsies will be collected prospectively for later analyses. Total number of patients to be included is 295 according to a power calculation. All patients in the clinical study will be included in the intervention group, while data on a historical control group will be obtained from The Danish Gynecological Cancer Database. Hence, the control group will consist of 1000 VC patients diagnosed between 2011-2022. Hypotheses: * All patients with VC will have specific tumor markers in the primary tumor that will be detectable in liquid biopsies as ctDNA at the time of diagnosis. * Measurement of ctDNA after primary treatment and during surveillance will allow detection of residual disease, improve allocation for adjuvant treatment, and will allow early detection of recurrent VC. * Proactive use of repeated PROM assessments in combination with procedural actions during surveillance will allow early detection of recurrent VC and early identification of late effects after treatment.

Key Facts

Lead Sponsor

University of Aarhus

Enrollment

1295

Start Date

2024-08-15

Completion Date

2028-12-31

Study Type

INTERVENTIONAL

Official Title

The Value of Patient-reported Outcome Measure Assessment and Circulating Tumor-DNA to Detect Early Relapse During Surveillance in Women With Vulva Cancer

Interventions

Measurement of circulating tumor-DNACollection of patient-reported outcomesAlgorithmically determined telephone interview with a nurse

Conditions

Vulva CancerVulva NeoplasmVulvar CancerVulva DiseaseVulvar NeoplasmsVulvar DiseasesPROMCirculating Tumor DNASurvivorship

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria:

* Primary or recurrent biopsy-verified squamous cell carcinoma of the vulva
* ≥ 18 years of age
* Able to understand oral and written information in Danish

Exclusion Criteria:

* Active treatment for concurrent cancer and/or dissemination of concurrent cancer

Outcome Measures

Primary Outcomes

Recurrence-free survival

Time frame: Two years

Overall survival

Time frame: Two years

Secondary Outcomes

Symptomatology preceding a recurrence

Time frame: Two years

Improved quality-of-life as a result of proactive management of late effects on an individual level

Time frame: Two years

Improved survival as a result of proactive management of late effects on group level

Time frame: Two years

ctDNA detection at time of diagnosis in relation to disease stage

Time frame: Two years

ctDNA detection after end of treatment in relation to residual disease

Time frame: Two years

ctDNA detection during surveillance in relation to recurrent disease

Time frame: Two years

Locations

Aarhus University Hospital, Aarhus N, Denmark

Copenhagen University Hospital, Copenhagen, Denmark

Linked Diseases

Vulvar Neoplasms

Vulvar Neoplasms — a type of gynecological cancer.