Table 3. Frequency of gynecologic cancer clinical trials with the return of value items based on ClinicalTrials.gov protocols, 1994 – 2021 (N = 279).
| ROV Item | Example of ROV Inclusion Items from Clinical Trial Protocols | No. of Protocols, N (%) |
|---|---|---|
| Basic information |
NCT02839707 Absolute neutrophil count (ANC) >= 1,500/mcl (within 14 days prior to registration) Platelets >= 100,000/mcl (within 14 days prior to registration) Hemoglobin (Hgb) >= 8 g/dl (within 14 days prior to registration) |
276 (99) |
| Information from medical record |
NCT01039207 Exclusion: Patients with thromboembolic event or ischemic event within the past 12 months, such as deep venous thrombosis, pulmonary embolism, transient ischemic attack, cerebral infarction, or myocardial infarction NCT00028951 No other malignancy within the past 5 years except nonmelanoma skin cancer. No nonhealing ulcer or chronic infection of the lower extremity, including superficial phlebitis. No prior fracture of any portion of either leg. |
276 (99) |
| Health-related quality of life (HRQOL) or Patient-reported outcome (PRO) questionnaires |
NCT00262847 Impact on Quality of Life Measured by the Functional Assessment of Cancer Therapy-Ovary Trial Outcome Index (FACT-O TOI). NCT00002568 Objective: Assess prospectively the quality of life (QOL) of these patients and determine whether secondary cytoreductive surgery affects QOL. |
56 (20) |
| How lifestyle affects the risk of getting a medical condition |
NCT00053261 Determine the association between smoking and vaginal length and between smoking and vaginal dryness in these patients after therapy for cervical cancer. NCT00003078 Must complete smoking history questionnaire and provide urine specimen for cotinine analysis. Compare the progression-free survival and survival of patients with advanced cervical cancer limited to the pelvis and who smoke at the time of diagnosis versus nonsmokers and those who smoke during radiation therapy versus those who quit. |
4 (1) |
| Biomarker testing |
NCT03556839 Secondary Outcome measures: incidence of anti-therapeutic antibodies (ATAs) during the study relative to the prevalence of ATAs at baseline NCT00003384 Evaluate the utility of MN protein, a novel tumor-associated antigen, as a potential diagnostic biomarker for cervical glandular and/or squamous neoplasia in patients with a cytologic diagnosis of atypical glandular cells of undetermined significance NCT01199263 To estimate (and compare) the proportion of patients who respond to the regimen on each arm of the study (according to Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 with measurable patients and by cancer antigen [CA]-125 for those patients with detectable disease only). |
114 (41) |
| Genetic testing |
NCT04034927 To explore whether mutations in BRCA1/2 genes or other evidence of homologous repair deficiency (HRD+) is prognostic and/or predictive of response to combined Olaparib and Tremelimumab immunotherapy. NCT03348631 To assess the clinical activity (response frequency) of tazemetostat in patients with recurrent or persistent clear cell ovarian carcinoma with an ARID1A mutation. |
57 (20) |
| Imaging report |
NCT00003128 Must have measurable disease consisting of abdominal, pelvic, chest or other masses that can be defined in at least 2 dimensions by palpation, x-ray, MRI, computed tomography or ultrasound. If measured by MRI, computed tomography or ultrasound, the lesion must have a minimal tumor measurement of 1 cm. NCT03738228 Secondary objectives: To assess the predictive value of baseline and on-treatment PD-L1 expression in the tissue in each treatment arm for clinical outcomes using post-treatment PET-CT scan and 2-year DFS as the outcome measures. |
229 (82) |
| Future use of participant information |
NCT01012297 Objective: To bank formalin-fixed and paraffin-embedded (FFPE) tumor tissue for research. NCT00551070 Previously collected archived tumor tissue samples are obtained to determine protein levels of p-ERK/ERKERK, DNA isolation and sequencing of BRAF and Ras mutation analysis by immunohistochemistry (IHC). |
30 (11) |
| Genetic ancestry | ----- | 0 (0) |
| How to connect with others in a study | ----- | 0 (0) |
| Remuneration | ----- | 0 (0) |