An observational study in Cognitive Side Effects of Cancer Therapy, Malignant Ovarian Epithelial Tumor and Ovarian Brenner Tumor, sponsored by Gynecologic Oncology Group. Completed at 182 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-12.
Sponsored by Gynecologic Oncology Group · Observational
Among 20 studies in Brenner Tumor by Gynecologic Oncology Group — none open to participants now, none under way, none of them phase 3. Brenner Tumor · Gynecologic Oncology Group.
Among the 20 studies in Brenner Tumor by Gynecologic Oncology Group, this one is the only one that started in 2010, is one of 3 observational ones, and was the 17th registered.
51 studies on the registry are indexed under Brenner Tumor; none are open to participants now.
Browse Brenner Tumor studies →None of the 20 studies in Brenner Tumor by Gynecologic Oncology Group is open now.
20 studies; the count open now beside each. This study's row is marked.
First in 1992; this study’s year is marked. 1 started in 2010.
Median enrollment 32 across the 13 interventional studies, 275 across the 3 observational. Of the 18 that completed or were terminated, 3 (17%) have results posted.
Gynecologic Oncology Group is the lead sponsor of 188 studies on the registry; 1 is open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 20 studies in Brenner Tumor by Gynecologic Oncology Group, from their registry updates:
Nothing recorded among them since 2026-09-25.
This clinical trial is studying changes in brain function in patients with stage I, stage II, stage III, or stage IV ovarian, primary peritoneal, or fallopian tube cancer who are receiving chemotherapy. Learning about the effects of chemotherapy on brain function may help doctors plan cancer treatments.
PRIMARY OBJECTIVE:
I. To describe changes in cognitive function among patients with ovarian, primary peritoneal, or fallopian tube cancer receiving front-line chemotherapy as measured by a web-based assessment of cognitive function as measured by the HeadMinder Customized Research Tool (CRT).
SECONDARY OBJECTIVES:
I. To estimate the proportion of these patients who experience possible or probable acute or persistent impairment in cognitive function while receiving chemotherapy as measured by a web-based assessment of cognitive function as measured by the HeadMinder CRT.
II. To explore the association between the patient-reported neurocognitive function as measured by the Patient Assessment of Own Functioning (PAF) scale and web-based assessment of cognitive function as measured by the HeadMinder CRT.
TERTIARY OBJECTIVES:
I. To explore the relationship between patient-reported quality of life as measured by the FACT-O and cognitive function as measured by the web-based and patient-reported assessments, respectively. (Exploratory) II. To explore whether the patient-reported cognitive function or the web-based assessment of cognitive function is associated with anxiety and depression as measured by the Hospital Anxiety and Depression Scale. (Exploratory) III. To explore the changes in cognitive function using the web-assessed (CRT) and self-reported (PAF) assessments, respectively, among patients with advanced ovarian cancer (stage III-IV, optimally debulked disease at enrollment) receiving IV as compared to intraperitoneal treatment. (Exploratory) IV. To explore whether the cognitive impairment as measured with web-based assessment is associated with patient age, hemoglobin, platelet count, patient-reported neurotoxicity symptoms as measured with FACT/GOG-Ntx subscale, or body weight. (Exploratory)
OUTLINE: This is a multicenter study.
Patients receive standard chemotherapy. Treatment repeats for 6 courses. Patients complete neurocognitive evaluations (Patient Assessment and Own Functioning scale and HeadMinder Custom Research Tool) and quality-of-life assessments (Hospital Anxiety and Depression Scale, FACT-O, and FACT/GOG-Ntx subscale) at baseline, before the fourth course of chemotherapy, at 3 weeks after the sixth course of chemotherapy, and at 6 months after the sixth course of chemotherapy.
Patients With Stage I, Stage II, Stage III, or Stage IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Who Are Receiving Chemotherapy
Inclusion Criteria:
Planning to receive ≥ 6 courses of front-line chemotherapy
No uncontrolled or severe cardiovascular disease, including any of the following:
More than 6 months since prior epoetin alfa, darbepoetin, or any forms of erythropoietin
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.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive standard chemotherapy. Treatment repeats for 6 courses. Patients complete neurocognitive evaluations (Patient Assessment and Own Functioning scale and HeadMinder Custom Research Tool) and quality-of-life assessments (Hospital Anxiety and Depression Scale, FACT-O, and FACT/GOG-Ntx subscale) at baseline, before the fourth course of chemotherapy, at 3 weeks after the sixth course of chemotherapy, and at 6 months after the sixth course of chemotherapy.
Procedure: Cognitive Assessment · Other: Quality-of-Life Assessment
Ancillary studies
Ancillary studies
Also known as: Quality of Life Assessment
Cognitive function as measured by the HeadMinder Customized Research Tool (CRT)
Time frame: Up to 6 months after completion of chemotherapy
Patient-reported cognitive function as measured by Patient Assessment Own Functioning scale and web CRT
Time frame: Up to 6 months after completion of chemotherapy
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This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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