A Study of the Effects of Chemotherapy on Fertility in Osteosarcoma (bone cancer) Survivors

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Age: 18 to 50 years old
Gender:
Male
Healthy Volunteers: No
Keywords: Osteosarcoma, fertility, fertility after chemotherapy, male fertility, male fertility after chemotherapy, male fertility after osteosarcoma
Type: Procedure study
Target:
2 Participants
Investigator:
Description
Incredible progress has been made in curing childhood cancers over the past 20 years. With all this success has come the awareness that childhood cancer treatment may lead to complications in some patients. This study is for patients who have previously received treatement for osteosarcoma (a type of bone cancer).

Some chemotherapy drugs cause fertility problems (difficulty fathering children) in male patients. We do not know if cisplatin with or without ifosfamide causes similar problems. Problems may occur later in life for patients initially treated as adolescents and young adults. We are doing this study to learn more about possible long-term effects.

The main goals of this study are:
• To look at potential effects on fertility in male osteosarcoma survivors treated with cisplatin with or without ifosfamide. This will be compared to male controls without a history of cancer.
• To learn whether cisplatin with or without ifosfamide changes the DNA in sperm.

The other goal of this study is:
• To explore how a person’s genetic makeup might change the effects that treatments for osteosarcoma have on male fertility.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

Inclusion Criteria:

Gender: Male

Age: Patients must be ≥ 18 and ≤ 50 years of age at the time of enrollment

Previous Enrollment: Previously enrolled and randomized on AOST0331 or CCG7921 (also known as INT0133 and POG9351)

Diagnosis: Osteosarcoma survivors without relapse or a subsequent malignancy other than skin cancer following initial treatment on AOST0331 or CCG7921 (also known as INT0133 and POG9351)

Language: Able to speak, read and write in English or Spanish

Regulatory Requirements All patients and/or their parents or legal guardians must sign a written informed consent.

All institutional, FDA, and NCI requirements for human studies must be met.

Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
We expect that it will take only about two to three months to finish your part in the study.
Recruitment period
From May 22, 2018
Location
UC Davis Comprehensive Cancer Center
4501 X Street
Sacramento, CA 95817
Research Topic
Conditions:
  • Cancer Survivor
  • Osteosarcoma

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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