CancerNCT02677311
GnRHA Therapy and Ovarian Preservation in Pediatric Cancer Patient
A study testing Blood draw and Pelvic Ultrasound in people with Cancer and Chemoradiation, run by University of Kentucky.
Trial summary
This is a prospective case control study. Participants will be enrolled as case subjects or control subjects, depending upon the gonadotoxicity of their chemoradiation therapy. The chemotherapeutic regimens will be determined per standard of care. Read more about this study
- Who is it for?
- Ages 8 to 19 years, women only
- Conditions the study is for
- Cancer, Chemoradiation
- What is being tested?
- Blood draw and Pelvic Ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to May 2017
- Phase
- Interventional
- 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 8 to 19 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Receiving chemoradiation therapy
- Documented ovarian function
- Require menstrual suppression with GnRHa during chemoradiation therapy
- Patients at the University of Kentucky, Norton Healthcare or Cincinnati Children's Hospital Medical Center
Who cannot join
- Under 8 years of age and older than 19 years of age
- Male
- Unable to provide consent or assent
About this study
Official title: Gonadotropin Releasing Hormone Agonist (GnRHa) Therapy and Ovarian Preservation in Pediatric and Adolescent Subject Receiving Chemoradiation Therap
This is a prospective case control study. Participants will be enrolled as case subjects or control subjects, depending upon the gonadotoxicity of their chemoradiation therapy. The chemotherapeutic regimens will be determined per standard of care. Participants will receive GnRHa (Lupron) as standard of care for menstrual suppression. Blood draws and pelvic ultrasound at baseline, 6 months and 12 months post completion of chemotherapy are the interventions. The duration of the study will be approximately 12 months.The study time includes the time necessary for completion of most cancer treatments in this population, which approximates 8-12 months, and time to allow complete excretion of the Lupron from the systemic circulation with reliable testing of the hypothalamic pituitary ovarian (H-P-O) axis. The results of the study will be used to guide a larger study evaluating the efficacy of gonadotropin releasing hormone agonist (GnRHa) as ovarian preservation therapy in young subjects receiving chemoradiation.
Read the detailed description
This study will not utilize a survey or questionnaire. Data will be collected via chart review and direct subject and/or guardian interviews.
Electronic medical records will be accessed only by approved clinical and research personnel to retrieve clinical and laboratory data.
At the initial visit, the following will be performed and collected on all subjects: Body Mass Index; age at thelarche; age at menarche; Tanner staging for breast and pubic hair; oncologic diagnosis; date of oncologic diagnosis; chemoradiation therapy treatment regimen; date of initiation of chemoradiation therapy; pre-treatment ovarian function blood tests; date GnRHa therapy initiated; a pelvic ultrasound will be performed to assess ovarian volumes and antral follicle count.
The subject will receive GnRHa 11.25 mg every 2 months until completion of chemotherapy, which is consistent with current clinical care at the University of Kentucky Medical Center (UKMC).
Study blood tests to evaluate ovarian function and pelvic ultrasound will be performed at three time points: immediately prior to initiation of GnRHa therapy and 6 and 12 months after chemoradiation therapy is completed.
The subject/guardian will be contacted by the study team at regular intervals to assess her progress and plan timing of study visits.
At subsequent visits, the investigator will record the date chemoradiation therapy treatment ended; date and reason GnRHa therapy discontinued; presence of breakthrough bleeding (BTB); timing of BTB in relation to most recent GnRHa injection. In order to document bleeding patterns, subjects will be asked to fill out the pictorial assessment of bleeding chart every month that they are in the study.
Six months after completion of chemoradiation therapy, the investigator will assess post-treatment ovarian function blood test levels and performed a pelvic U/S to assess ovarian volumes and antral follicle count. Investigator will as assess the resumption of spontaneous menses, parity, date of subject demise, if applicable.
Twelve months after completion of chemotherapy, we will assess post-treatment ovarian function blood test levels; and performed a pelvic U/S to assess ovarian volumes and antral follicle count. Investigator will as assess the resumption of spontaneous menses, parity, date of subject demise, if applicable.
- Conditions
- Cancer, Chemoradiation
- Being tested
- Blood draw, Pelvic Ultrasound
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawProcedure or surgery
Blood draws will be performed immediately prior to GnRHa treatment and at 6 and 12 months following treatment completion
Pelvic UltrasoundProcedure or surgery
Pelvic ultrasound will be performed immediately prior to GnRHa treatment and at 6 and 12 months following treatment completion
| Study group | Role | What they receive |
|---|---|---|
| Cases | Other | Participants who will receive gonadotoxic chemoradiation therapies to include the alkylating agents, heavy metals and plant alkaloids as a standard part of their cancer treatment. Participants will also receive the GnRHa for menstrual suppression as part of standard of care. Baseline blood draws and pelvic ultrasound will be the intervention. Repeat blood draws and pelvic ultrasound at 6 and 12 months will also be interventions. Receives: Procedure: Blood draw; Procedure: Pelvic Ultrasound |
| Controls | Other | Participants who will receive chemoradiation therapies presumed to be low risk for gonadotoxicity as determined by the literature and the patient's oncolologist as a standard part of their cancer treatment. Participants will also receive the GnRHa for menstrual suppression as part of standard of care. Baseline blood draws and pelvic ultrasound will be the intervention. Repeat blood draws and pelvic ultrasound at 6 and 12 months will also be interventions. Receives: Procedure: Blood draw; Procedure: Pelvic Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovarian Reserve - AMH
Assess AMH change from baseline to 6 months.
Measured: 6 months post completion of chemotherapy
Ovarian Reserve - AMH
Assess AMH change from baseline to 12 months.
Measured: 12 months post completion of chemotherapy
Ovarian Reserve - Menstrual function
Assess menstrual function change from baseline to 12 year.
Measured: 12 months post completion of chemotherapy
Ovarian Reserve - FSH
Assess FSH change from baseline to 6 months.
Measured: 6 months post completion of chemotherapy
Ovarian Reserve - FSH
Assess FSH change from baseline to 12 months.
Measured: 12 months post completion of chemotherapy
Ovarian Reserve - Menstrual function
Assess menstrual function change from baseline to 6 months.
Measured: 6 months post completion of chemotherapy
Secondary outcomes (1)
Ovarian Reserve - Agreement of AMH and AFC
To assess the agreement of AMH (< or equal to 0.5 vs. > 0.5) and AFC (<16 follicles vs 16+ follicles) as indicators of ovarian reserve after chemoradiation and GnRHa therapy
Measured: Pre-GnRHa therapy, 6 months post and 12 post completion of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startSep 2015
- Primary completionMay 2017
- Study completionMay 2017
Why it stopped: Unable to recruit required numbers for study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kentucky
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02677311
- Sponsor's protocol ID
- 15-0596-F2L
- Status last verified
- May 2017
- First submitted
- 20 Dec 2015
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: * UK IRB/Office of Research Integrity * Law enforcement agencies when required by law * University of Kentucky representatives * UK Hospital * ACOG * Representatives of the National Cancer Institute (NCI), FDA, and other U.S. and international governmental regulatory agencies involved in overseeing research * Authorized representatives at the University of Cincinnati who are collaborating on this research. * Every research site of the study (including UK Healthcare and Cincinnati Children's and each site's research staff and medical staff) * Every health care provider who provides services to you in connection with the study * Any laboratories and other individuals and organizations that analyze your PHI in connection with the study * The Sponsor and the people and companies they use to oversee, administer and/or conduct the study * Kentucky Cancer Registry (KCR) to all follow-up assistance
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gonadotropin Releasing Hormone Agonist (GnRHa) Therapy and Ovarian Preservation in Pediatric and Adolescent Subject Receiving Chemoradiation Therap
- ClinicalTrials.gov ID
- NCT02677311
- Acronym / sponsor ID
- 15-0596-F2L
- Conditions
- Cancer, Chemoradiation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit required numbers for study.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of KentuckyUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 9 Feb 2016 (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 is a prospective case control study. Participants will be enrolled as case subjects or control subjects, depending upon the gonadotoxicity of their chemoradiation therapy. The chemotherapeutic regimens will be determined per standard of care. Participants will receive GnRHa (Lupron) as standard of care for menstrual suppression. Blood draws and pelvic ultrasound at baseline, 6 months and 12 months post completion of chemotherapy are the interventions. The duration of the study will be approximately 12 months.The study time includes the time necessary for completion of most cancer treatments in this population, which approximates 8-12 months, and time to allow complete excretion of the Lupron from the systemic circulation with reliable testing of the hypothalamic pituitary ovarian (H-P-O) axis. The results of the study will be used to guide a larger study evaluating the efficacy of gonadotropin releasing hormone agonist (GnRHa) as ovarian preservation therapy in young subjects receiving chemoradiation.
Detailed description
This study will not utilize a survey or questionnaire. Data will be collected via chart review and direct subject and/or guardian interviews.
Electronic medical records will be accessed only by approved clinical and research personnel to retrieve clinical and laboratory data.
At the initial visit, the following will be performed and collected on all subjects: Body Mass Index; age at thelarche; age at menarche; Tanner staging for breast and pubic hair; oncologic diagnosis; date of oncologic diagnosis; chemoradiation therapy treatment regimen; date of initiation of chemoradiation therapy; pre-treatment ovarian function blood tests; date GnRHa therapy initiated; a pelvic ultrasound will be performed to assess ovarian volumes and antral follicle count.
The subject will receive GnRHa 11.25 mg every 2 months until completion of chemotherapy, which is consistent with current clinical care at the University of Kentucky Medical Center (UKMC).
Study blood tests to evaluate ovarian function and pelvic ultrasound will be performed at three time points: immediately prior to initiation of GnRHa therapy and 6 and 12 months after chemoradiation therapy is completed.
The subject/guardian will be contacted by the study team at regular intervals to assess her progress and plan timing of study visits.
At subsequent visits, the investigator will record the date chemoradiation therapy treatment ended; date and reason GnRHa therapy discontinued; presence of breakthrough bleeding (BTB); timing of BTB in relation to most recent GnRHa injection. In order to document bleeding patterns, subjects will be asked to fill out the pictorial assessment of bleeding chart every month that they are in the study.
Six months after completion of chemoradiation therapy, the investigator will assess post-treatment ovarian function blood test levels and performed a pelvic U/S to assess ovarian volumes and antral follicle count. Investigator will as assess the resumption of spontaneous menses, parity, date of subject demise, if applicable.
Twelve months after completion of chemotherapy, we will assess post-treatment ovarian function blood test levels; and performed a pelvic U/S to assess ovarian volumes and antral follicle count. Investigator will as assess the resumption of spontaneous menses, parity, date of subject demise, if applicable.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | Other | Procedure: Blood draw, Procedure: Pelvic UltrasoundParticipants who will receive gonadotoxic chemoradiation therapies to include the alkylating agents, heavy metals and plant alkaloids as a standard part of their cancer treatment. Participants will also receive the GnRHa for menstrual suppression as part of standard of care. Baseline blood draws and pelvic ultrasound will be the intervention. Repeat blood draws and pelvic ultrasound at 6 and 12 months will also be interventions. |
| Controls | Other | Procedure: Blood draw, Procedure: Pelvic UltrasoundParticipants who will receive chemoradiation therapies presumed to be low risk for gonadotoxicity as determined by the literature and the patient's oncolologist as a standard part of their cancer treatment. Participants will also receive the GnRHa for menstrual suppression as part of standard of care. Baseline blood draws and pelvic ultrasound will be the intervention. Repeat blood draws and pelvic ultrasound at 6 and 12 months will also be interventions. |
Who may qualify
- Ages
- 8 to 19 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Receiving chemoradiation therapy
- Documented ovarian function
- Require menstrual suppression with GnRHa during chemoradiation therapy
- Patients at the University of Kentucky, Norton Healthcare or Cincinnati Children's Hospital Medical Center
Key exclusion criteria (3 listed)
- Under 8 years of age and older than 19 years of age
- Male
- Unable to provide consent or assent
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 |
|---|---|---|
| Blood drawBlood draws will be performed immediately prior to GnRHa treatment and at 6 and 12 months following treatment completion | Procedure or surgery | Cases, Controls |
| Pelvic UltrasoundPelvic ultrasound will be performed immediately prior to GnRHa treatment and at 6 and 12 months following treatment completion | Procedure or surgery | Cases, Controls |
Primary outcome
Ovarian Reserve - AMH
Time frame: 6 months post completion of chemotherapy
Assess AMH change from baseline to 6 months.
Ovarian Reserve - AMH
Time frame: 12 months post completion of chemotherapy
Assess AMH change from baseline to 12 months.
Ovarian Reserve - Menstrual function
Time frame: 12 months post completion of chemotherapy
Assess menstrual function change from baseline to 12 year.
Ovarian Reserve - FSH
Time frame: 6 months post completion of chemotherapy
Assess FSH change from baseline to 6 months.
Ovarian Reserve - FSH
Time frame: 12 months post completion of chemotherapy
Assess FSH change from baseline to 12 months.
Ovarian Reserve - Menstrual function
Time frame: 6 months post completion of chemotherapy
Assess menstrual function change from baseline to 6 months.
1 secondary outcome
Ovarian Reserve - Agreement of AMH and AFC
Time frame: Pre-GnRHa therapy, 6 months post and 12 post completion of chemotherapy
Results and safety
The study was stopped early (reason given: Unable to recruit required numbers for study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
- Individual participant dataSharing planned: Yes. * UK IRB/Office of Research Integrity * Law enforcement agencies when required by law * University of Kentucky representatives * UK Hospital * ACOG * Representatives of the National Cancer Institute (NCI), FDA, and other U.S. and international governmental regulatory agencies involved in overseeing research * Authorized representatives at the University of Cincinnati who are collaborating on this research. * Every research site of the study (including UK Healthcare and Cincinnati Children's and each site's research staff and medical staff) * Every health care provider who provides services to you in connection with the study * Any laboratories and other individuals and organizations that analyze your PHI in connection with the study * The Sponsor and the people and companies they use to oversee, administer and/or conduct the study * Kentucky Cancer Registry (KCR) to all follow-up assistance
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Blood draw and Pelvic Ultrasound in people with Cancer and Chemoradiation, run by University of Kentucky.
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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was stopped early (reason given: Unable to recruit required numbers for study.). Results are not available in the source record.
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?
Ovarian Reserve - AMH (time frame: 6 months post completion of chemotherapy). The study lists 6 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 26 Oct 2017.