Adnexal MassPhase 1NCT02520115
Folate Receptor in Diagnosing Ovarian Cancer Using Serum Samples From Patients With Newly Diagnosed Pelvic Mass or Previously Diagnosed Ovarian Cancer
A Phase 1 study testing Dexamethasone, Laboratory Biomarker Analysis and Valproic Acid in people with Adnexal Mass and Borderline Ovarian Epithelial Tumor, run by Barbara Ann Karmanos Cancer Institute at 2 sites in United States.
Trial summary
This pilot research trial studies folate receptor in diagnosing ovarian cancer using serum samples from patients with a newly diagnosed pelvic mass or previously diagnosed ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Adnexal Mass, Borderline Ovarian Epithelial Tumor, Ovarian Clear Cell Tumor
- What is being tested?
- Dexamethasone, Laboratory Biomarker Analysis and Valproic Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2015to Nov 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For study Arm 1, female subjects of childbearing potential or less than 2 years postmenopausal agree to use an acceptable form of contraception from the time of signing informed consent until 30 days after study completion unless total hysterectomy performed at the time of original operation
- Able to provide informed consent
- Performance status Eastern Cooperative Oncology Group (ECOG) 0-2
- Study Arm 1: primary diagnosis of a pelvic or adnexal mass of presumed gynecologic origin who is scheduled for operative resection
- Study Arm 2: previously diagnosed with a non-mucinous epithelial ovarian carcinoma (including serous, clear cell, and endometrioid histologies as well as borderline ovarian tumors) currently undergoing routine surveillance for recurrence, having been diagnosed with recurrence but prior to initiation of chemotherapy. . Patients from Study Arm 1 will automatically be included in Study Arm 2 as well unless they withdraw consent. Finally, patients who have been diagnosed with an ovarian cancer of acceptable histology but not yet initiated adjuvant chemotherapy are eligible for Study Arm 2.
Who cannot join
- Known sarcomatous histologies
- Current usage of VPA or Dex, if patient has been on these medications in the past but is not currently taking them she is still a candidate for the study. Prior use must be greater than one month for VPA. There is no "wash out" period required for DEX.
- Any contraindication to dexamethasone or valproic acid such as known allergies or sensitivity
- Unable to give informed consent
- Pregnancy
- Greater than 3 x the upper limit of normal (ULN) for alanine aminotransferase (ALT), aspartate aminotransferase (AST)
Show all 12Show fewer
- Greater than 3 x the ULN for total bilirubin (except for known cases of Gilbert's syndrome, where the levels of conjugated bilirubin must be less than 3 x the ULN)
- Greater than 1.5 x the ULN for blood urea nitrogen (BUN)
- Greater than 1.5 x the ULN for creatinine
- Chronic or acute pancreatitis as evidenced by clinical or pathologic diagnosis
- Significant acute or chronic medical, neurologic, or psychiatric illness in the subject that, in the judgment of the Investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study
- For study Arm 2, patients that are currently undergoing chemotherapy for recurrence; maintenance chemotherapy is not considered an exclusion criteria. Additionally, as noted above if a patient has not yet begun chemotherapy for recurrence or adjuvant chemotherapy for initial diagnosis they are still a candidate to be enrolled on this Study arm.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Karmanos Cancer Institute at McLaren Bay Region, Bay City
Bay City, Michigan, 48706
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201
About this study
Official title: Study of Serum Measured Folate Receptor and Its Induction as a Biomarker in the Diagnosis and Surveillance of Ovarian Carcinoma
This pilot research trial studies folate receptor in diagnosing ovarian cancer using serum samples from patients with a newly diagnosed pelvic mass or previously diagnosed ovarian cancer. Studying samples of serum from patients with ovarian cancer in the laboratory may help understand the use of folate receptor induction as a clinical tool in initial diagnosis, surveillance, and recurrence.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the pre- and post-induction correlation between soluble folate receptor and tumor-based receptor levels as a marker of malignancy in patients with newly diagnosed adnexal masses. (Arm I) II. To evaluate the ability to induce serum folate receptor (FR) with dexamethasone (Dex) and valproic acid (VPA) treatment in patients with newly diagnosed adnexal masses. (Arm I) III. To evaluate the use of the serum soluble FR as a marker for earlier detection of recurrent disease. (Arm II) IV. To evaluate the ability to induce FR with Dex and VPA in the setting of recurrent disease. (Arm II)
SECONDARY OBJECTIVES:
- To evaluate the expression of FR in primary versus (vs.) metastatic tumor sites in patients with ovarian malignancy undergoing Dex and VPA induction and correlate expression with other markers associated with malignancy (marker of proliferation Ki-67 [Ki67], cancer antigen [CA]-125, etc.).
II. To analyze the correlation between gluco-corticoid receptor (GR) levels and serum FR induction efficacy.
III. To examine global, downstream targets of GR and FR induction in patient samples undergoing treatment with Dex and VPA.
OUTLINE: Patients are assigned to 1 of 2 arms.
ARM I (INDUCTION): Patients receive valproic acid orally (PO) twice daily (BID) on days -7 to -3 and once daily (QD) on day -2 and dexamethasone PO QD on days -5 and -2 and BID on days -4 and -3. Patients undergo collection of serum and tissue samples for analysis via polymerase chain reaction (PCR) and immunohistochemistry (IHC) at baseline, time of surgery, and 7-14 days after surgery.
ARM II (SURVEILLANCE AND RECURRENCE): Patients receive valproic acid PO BID on days -7 to -3 and QD on day -2 and dexamethasone PO QD on days -5 and -2 and BID on days -4 and -3. Patients undergo collection of serum and tissue samples for analysis via PCR and IHC at the time of clinically suspected recurrence, 2 days after completion of induction, and 7-14 days after induction.
- Conditions
- Adnexal Mass, Borderline Ovarian Epithelial Tumor, Ovarian Clear Cell Tumor, Ovarian Endometrioid Tumor, Ovarian Neoplasm, Ovarian Serous Tumor
- Being tested
- Dexamethasone, Laboratory Biomarker Analysis, Valproic Acid
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex
Given PO
Laboratory Biomarker AnalysisOther
Analysis of serum and tissue samples
Valproic AcidDrug
Also called Depakene, Stavzor, Valproate
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Arm I (induction) | Experimental | Patients receive valproic acid PO BID on days -7 to -3 and QD on day -2 and dexamethasone PO QD on days -5 and -2 and BID on days -4 and -3. Patients undergo collection of serum and tissue samples for analysis via PCR and IHC at baseline, time of surgery, and 7-14 days after surgery. Receives: Drug: Dexamethasone; Other: Laboratory Biomarker Analysis; Drug: Valproic Acid |
| Arm II (surveillance and recurrence) | Experimental | Patients receive valproic acid PO BID on days -7 to -3 and QD on day -2 and dexamethasone PO QD on days -5 and -2 and BID on days -4 and -3. Patients undergo collection of serum samples for analysis via PCR and IHC at the time of clinically suspected recurrence, 2 days after completion of induction, and 7-14 days after induction. Receives: Drug: Dexamethasone; Other: Laboratory Biomarker Analysis; Drug: Valproic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arm I: To evaluate the ability to increase serum Folate Receptor (FR) levels in patients with newly diagnosed adnexal masses or ovarian cancer utilizing Dexamethasone (DEX) and Valproic Acid (VA).
FR will be measured in the serum of patients utilizing a standardized tritiated folate/charcoal binding assay pre- and post-drug administration. This will be measured to the femto-molar level. Two sided t-tests will be utilized as a baseline statistical analysis to determine the efficacy of induction in this setting.
Measured: Up to 14 days after induction
Arm I: To evaluate the utility of serum FR to distinguish between patients with benign masses or malignancy.
Folate receptor levels in patients with benign and malignant conditions will be compared utilizing receiver operator curves for both pre- and post-induction levels to determine if soluble folate receptor can be utilized as a tumor marker in newly diagnosed adnexal masses and/or ovarian cancer. Both two-sided t tests and ROC curve analysis will be utilized in this portion of the analysis.
Measured: Up to 14 days after surgery
Arm II: To evaluate the use of the serum soluble FR as a marker for earlier detection of recurrent disease.
Patients are to be followed during surveillance period for a history of know ovarian carcinoma with serum FR in addition to CA-125. FR will again be measured in the serum of patients utilizing a standardized tritiated folate/charcoal binding assay. This will be measured to the femto-molar level. ROC curve analysis will be performed to evaluate the efficacy of baseline Folate Receptor in early detection of relapse and compared to standard tumor markers such as CA-125.
Measured: Up to 14 days after induction
Arm II: To evaluate the ability to increase serum FR levels with DEX and VA in the setting of recurrent disease.
If recurrence is suspected, this portion of Arm 2 is meant to determine if serum levels of FR can be artificially increased in the recurrent setting utilizing DEX and VA above baseline recurrent levels. FR will be measured in the serum of patients utilizing a standardized tritiated folate/charcoal binding assay pre- and post-drug administration. This will be measured to the femto-molar level. Two side t-tests will be utilized to determine the efficacy of induction in this setting.
Measured: Up to 14 days after surgery
Secondary outcomes (3)
Arm I: To evaluate expression of FR via immunohistochemistry in primary vs. metastatic tumor sites in patients with ovarian malignancy undergoing DEX & VA induction and determine if this correlates with other known markers associated with malignancy.
Two sided independent t-tests will be performed to compare the expression of FR in primary vs metastatic tumor sites. Pearson's correlation coefficients will be calculated to evaluate the associations between serum FR and existing markers such as Ki67 and CA-125.
Measured: Up to day 14
Arm I: To examine downstream targets of GR and FR induction in patient samples undergoing treatment with DEX and VA via global mRNA analysis and proteomic modalities.
Achieved by utilizing such techniques (but not limited to) as transcriptome analysis and whole genome Chip analysis.
Measured: Up to day 14
Arm I: To analyze the correlation between GR level as noted by immunohistochemistry and serum FR induction efficacy with DEX and VA.
Pearson's correlation coefficients will be calculated to evaluate the associations between serum Folate receptor levels and tissue based glucocorticoid receptors.
Measured: Up to day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionSep 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adnexal MassStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Ira Winer, Barbara Ann Karmanos Cancer Institute
- Investigators
- Ira Winer, Principal investigator, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02520115
- Sponsor's protocol ID
- 2015-024
- Other IDs
- NCI-2015-01039, 1504013983, 2015-024, P30CA022453
- Status last verified
- Aug 2019
- First submitted
- 30 Jul 2015
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Serum Measured Folate Receptor and Its Induction as a Biomarker in the Diagnosis and Surveillance of Ovarian Carcinoma
- ClinicalTrials.gov ID
- NCT02520115
- Acronym / sponsor ID
- 2015-024
- Conditions
- Adnexal Mass, Borderline Ovarian Epithelial Tumor, Ovarian Clear Cell Tumor, Ovarian Endometrioid Tumor, Ovarian Neoplasm, Ovarian Serous Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2015
- Primary completion
- Sep 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 11 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot research trial studies folate receptor in diagnosing ovarian cancer using serum samples from patients with a newly diagnosed pelvic mass or previously diagnosed ovarian cancer. Studying samples of serum from patients with ovarian cancer in the laboratory may help understand the use of folate receptor induction as a clinical tool in initial diagnosis, surveillance, and recurrence.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the pre- and post-induction correlation between soluble folate receptor and tumor-based receptor levels as a marker of malignancy in patients with newly diagnosed adnexal masses. (Arm I) II. To evaluate the ability to induce serum folate receptor (FR) with dexamethasone (Dex) and valproic acid (VPA) treatment in patients with newly diagnosed adnexal masses. (Arm I) III. To evaluate the use of the serum soluble FR as a marker for earlier detection of recurrent disease. (Arm II) IV. To evaluate the ability to induce FR with Dex and VPA in the setting of recurrent disease. (Arm II)
SECONDARY OBJECTIVES:
- To evaluate the expression of FR in primary versus (vs.) metastatic tumor sites in patients with ovarian malignancy undergoing Dex and VPA induction and correlate expression with other markers associated with malignancy (marker of proliferation Ki-67 [Ki67], cancer antigen [CA]-125, etc.).
II. To analyze the correlation between gluco-corticoid receptor (GR) levels and serum FR induction efficacy.
III. To examine global, downstream targets of GR and FR induction in patient samples undergoing treatment with Dex and VPA.
OUTLINE: Patients are assigned to 1 of 2 arms.
ARM I (INDUCTION): Patients receive valproic acid orally (PO) twice daily (BID) on days -7 to -3 and once daily (QD) on day -2 and dexamethasone PO QD on days -5 and -2 and BID on days -4 and -3. Patients undergo collection of serum and tissue samples for analysis via polymerase chain reaction (PCR) and immunohistochemistry (IHC) at baseline, time of surgery, and 7-14 days after surgery.
ARM II (SURVEILLANCE AND RECURRENCE): Patients receive valproic acid PO BID on days -7 to -3 and QD on day -2 and dexamethasone PO QD on days -5 and -2 and BID on days -4 and -3. Patients undergo collection of serum and tissue samples for analysis via PCR and IHC at the time of clinically suspected recurrence, 2 days after completion of induction, and 7-14 days after induction.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (induction) | Experimental | Drug: Dexamethasone, Other: Laboratory Biomarker Analysis, Drug: Valproic AcidPatients receive valproic acid PO BID on days -7 to -3 and QD on day -2 and dexamethasone PO QD on days -5 and -2 and BID on days -4 and -3. Patients undergo collection of serum and tissue samples for analysis via PCR and IHC at baseline, time of surgery, and 7-14 days after surgery. |
| Arm II (surveillance and recurrence) | Experimental | Drug: Dexamethasone, Other: Laboratory Biomarker Analysis, Drug: Valproic AcidPatients receive valproic acid PO BID on days -7 to -3 and QD on day -2 and dexamethasone PO QD on days -5 and -2 and BID on days -4 and -3. Patients undergo collection of serum samples for analysis via PCR and IHC at the time of clinically suspected recurrence, 2 days after completion of induction, and 7-14 days after induction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- For study Arm 1, female subjects of childbearing potential or less than 2 years postmenopausal agree to use an acceptable form of contraception from the time of signing informed consent until 30 days after study completion unless total hysterectomy performed at the time of original operation
- Able to provide informed consent
- Performance status Eastern Cooperative Oncology Group (ECOG) 0-2
- Study Arm 1: primary diagnosis of a pelvic or adnexal mass of presumed gynecologic origin who is scheduled for operative resection
- Study Arm 2: previously diagnosed with a non-mucinous epithelial ovarian carcinoma (including serous, clear cell, and endometrioid histologies as well as borderline ovarian tumors) currently undergoing routine surveillance for recurrence, having been diagnosed with recurrence but prior to initiation of chemotherapy. . Patients from Study Arm 1 will automatically be included in Study Arm 2 as well unless they withdraw consent. Finally, patients who have been diagnosed with an ovarian cancer of acceptable histology but not yet initiated adjuvant chemotherapy are eligible for Study Arm 2.
Key exclusion criteria (12 listed)
- Known sarcomatous histologies
- Current usage of VPA or Dex, if patient has been on these medications in the past but is not currently taking them she is still a candidate for the study. Prior use must be greater than one month for VPA. There is no "wash out" period required for DEX.
- Any contraindication to dexamethasone or valproic acid such as known allergies or sensitivity
- Unable to give informed consent
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneAlso: Aacidexam, Adexone, Aknichthol Dexa, Alba-DexGiven PO | Drug | Arm I (induction), Arm II (surveillance and recurrence) |
| Laboratory Biomarker AnalysisAnalysis of serum and tissue samples | Other | Arm I (induction), Arm II (surveillance and recurrence) |
| Valproic AcidAlso: Depakene, Stavzor, ValproateGiven PO | Drug | Arm I (induction), Arm II (surveillance and recurrence) |
Primary outcome
Arm I: To evaluate the ability to increase serum Folate Receptor (FR) levels in patients with newly diagnosed adnexal masses or ovarian cancer utilizing Dexamethasone (DEX) and Valproic Acid (VA).
Time frame: Up to 14 days after induction
FR will be measured in the serum of patients utilizing a standardized tritiated folate/charcoal binding assay pre- and post-drug administration. This will be measured to the femto-molar level. Two sided t-tests will be utilized as a baseline statistical analysis to determine the efficacy of induction in this setting.
Arm I: To evaluate the utility of serum FR to distinguish between patients with benign masses or malignancy.
Time frame: Up to 14 days after surgery
Folate receptor levels in patients with benign and malignant conditions will be compared utilizing receiver operator curves for both pre- and post-induction levels to determine if soluble folate receptor can be utilized as a tumor marker in newly diagnosed adnexal masses and/or ovarian cancer. Both two-sided t tests and ROC curve analysis will be utilized in this portion of the analysis.
Arm II: To evaluate the use of the serum soluble FR as a marker for earlier detection of recurrent disease.
Time frame: Up to 14 days after induction
Patients are to be followed during surveillance period for a history of know ovarian carcinoma with serum FR in addition to CA-125. FR will again be measured in the serum of patients utilizing a standardized tritiated folate/charcoal binding assay. This will be measured to the femto-molar level. ROC curve analysis will be performed to evaluate the efficacy of baseline Folate Receptor in early detection of relapse and compared to standard tumor markers such as CA-125.
Arm II: To evaluate the ability to increase serum FR levels with DEX and VA in the setting of recurrent disease.
Time frame: Up to 14 days after surgery
If recurrence is suspected, this portion of Arm 2 is meant to determine if serum levels of FR can be artificially increased in the recurrent setting utilizing DEX and VA above baseline recurrent levels. FR will be measured in the serum of patients utilizing a standardized tritiated folate/charcoal binding assay pre- and post-drug administration. This will be measured to the femto-molar level. Two side t-tests will be utilized to determine the efficacy of induction in this setting.
3 secondary outcomes
Arm I: To evaluate expression of FR via immunohistochemistry in primary vs. metastatic tumor sites in patients with ovarian malignancy undergoing DEX & VA induction and determine if this correlates with other known markers associated with malignancy.
Time frame: Up to day 14
Arm I: To examine downstream targets of GR and FR induction in patient samples undergoing treatment with DEX and VA via global mRNA analysis and proteomic modalities.
Time frame: Up to day 14
Arm I: To analyze the correlation between GR level as noted by immunohistochemistry and serum FR induction efficacy with DEX and VA.
Time frame: Up to day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
Related trials for Adnexal Mass
RecruitingObservational study
Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer
Endometrial Cancer, Cervical Cancer
Recruiting
MIRRORS-FROZEN - Comparing Open Vs Robotic Surgery in the Management of Women With Complex Pelvic Adnexal Masses ≤ 8cm.
Ovarian Cancer, Ovarian Mass
Active, not recruitingObservational study
A Diagnostic Test to Evaluate Cancer Risk Before Surgery in Women With an Ovarian Mass
Ovarian Neoplasms
Not yet recruitingObservational study
Chinese Overweight/Obesity Cohort: Metabolic & Comorbidity Risks
Obesity & Overweight, Diabetes Mellitus, Type 2
Not yet recruitingObservational study
AI Analysis of CT Scans to Classify Ovarian Tumours as Benign, Borderline or Malignant Before Surgery
Ovarian Cancer, Ovarian Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ira Winer principal investigator
Barbara Ann Karmanos Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dexamethasone, Laboratory Biomarker Analysis and Valproic Acid in people with Adnexal Mass and Borderline Ovarian Epithelial Tumor, run by Barbara Ann Karmanos Cancer Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arm I: To evaluate the ability to increase serum Folate Receptor (FR) levels in patients with newly diagnosed adnexal masses or ovarian cancer utilizing Dexamethasone (DEX) and Valproic Acid (VA). (time frame: Up to 14 days after induction). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2019.