Hodgkin LymphomaFertHDNCT01008735
Gonadal Toxicity in Women With Hodgkin Lymphoma
An observational study of Hodgkin Lymphoma, run by Gruppo Italiano Studio Linfomi at 1 site in Italy.
Trial summary
The Gruppo Italiano Studio Linfomi has been collecting data on patients with Hodgkin Lymphoma (HL) since 1988. This archive represents a homogeneous series of consecutive patients with HL. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Hodgkin Lymphoma
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2009to not given
- Phase
- Observational
- 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 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Female patients with Hodgkin lymphoma diagnosed until 2007 in Italy will be considered eligible for this study. Cases will be identified from the archives of GISL.
Who may be able to join
- Female patients in complete remission after chemotherapy for Hodgkin lymphoma
- Age ≥ 18 e < 40 years
- Previous regular menstrual cycle
- No previous or concomitant gynecological diseases affecting reproducing function
- No other chemo-radiotherapy for other neoplasm
- Written informed consent
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Gruppo Italiano Studio Linfomi
Modena
Antonella Montanini, BSc, PhD, +39 059 4223284, amontanini@unimore.it
Massimo Federico, MD
About this study
Official title: Observational Retrospective Study to Evaluate the Incidence of the Gonadal Toxicity in Women of Reproductive Age With Hodgkin Lymphoma
The Gruppo Italiano Studio Linfomi has been collecting data on patients with Hodgkin Lymphoma (HL) since 1988. This archive represents a homogeneous series of consecutive patients with HL. The very long follow up and the availability of clinical and treatment data make it feasible to perform a study on the gonadal toxicity related to treatment for HL.
- Conditions
- Hodgkin Lymphoma
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| women with hodgkin lymphoma treated with chemotherapy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of gonadal toxicity in terms of irreversible amenorrhea and infertility, in women of reproductive age with Hodgkin lymphoma treated with chemotherapy.
Measured: from end of treatment until date of last contact/visit
Secondary outcomes (1)
role of a prophylactic treatment with oral contraceptives and GnRH analogs in preventing gonadal damage
Measured: from end of treatment until date of last contact/visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2009 (estimated)
- Study startJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin LymphomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Studio Linfomi
- Sponsor type
- University, hospital or other
- Investigators
- Francesco Angrilli, MD, Study chair, GISLSimona Falorio, MD, Study chair, GISLMassimo Federico, MD, Study chair, GISL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01008735
- Sponsor's protocol ID
- FertHD
- Acronym
- FertHD
- Status last verified
- Nov 2009
- First submitted
- 3 Nov 2009
- Last updated
- 13 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Retrospective Study to Evaluate the Incidence of the Gonadal Toxicity in Women of Reproductive Age With Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT01008735
- Acronym / sponsor ID
- FertHD / FertHD
- Conditions
- Hodgkin Lymphoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Gruppo Italiano Studio LinfomiUniversity, hospital or other
- Study start
- Jul 2009
- First posted
- 6 Nov 2009 (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.
The Gruppo Italiano Studio Linfomi has been collecting data on patients with Hodgkin Lymphoma (HL) since 1988. This archive represents a homogeneous series of consecutive patients with HL. The very long follow up and the availability of clinical and treatment data make it feasible to perform a study on the gonadal toxicity related to treatment for HL.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| women with hodgkin lymphoma treated with chemotherapy | – | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Female patients with Hodgkin lymphoma diagnosed until 2007 in Italy will be considered eligible for this study. Cases will be identified from the archives of GISL.
Key inclusion criteria (6 listed)
- Female patients in complete remission after chemotherapy for Hodgkin lymphoma
- Age ≥ 18 e < 40 years
- Previous regular menstrual cycle
- No previous or concomitant gynecological diseases affecting reproducing function
- No other chemo-radiotherapy for other neoplasm
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
incidence of gonadal toxicity in terms of irreversible amenorrhea and infertility, in women of reproductive age with Hodgkin lymphoma treated with chemotherapy.
Time frame: from end of treatment until date of last contact/visit
1 secondary outcome
role of a prophylactic treatment with oral contraceptives and GnRH analogs in preventing gonadal damage
Time frame: from end of treatment until date of last contact/visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2009.
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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.
Francesco Angrilli, MD study chair
GISL
Simona Falorio, MD study chair
GISL
Massimo Federico, MD study chair
GISL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hodgkin Lymphoma, run by Gruppo Italiano Studio Linfomi at 1 site in Italy.
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 6 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 13 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonella Montanini, BSc, PhD (+39 059 4223284, amontanini@unimore.it\), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of gonadal toxicity in terms of irreversible amenorrhea and infertility, in women of reproductive age with Hodgkin lymphoma treated with chemotherapy. (time frame: from end of treatment until date of last contact/visit). 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 13 Nov 2009.