Genetic Study of Familial Acute Lymphoblastic Leukemia
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Blood Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 12/19/2018 |
| Start Date: | May 9, 2017 |
| End Date: | May 2027 |
Familial aggregation is well recognized in some cancers. Though a number of familial cancer
predisposition syndromes have been described, the nature of inherited genetic alterations in
patients with a strong history of familial cancer is currently unknown, as is the case with
childhood acute lymphoblastic leukemia (ALL).
The investigators are seeking to learn more about what causes leukemia and why some people
and families may be at a higher risk of developing this disease. By understanding the origin
of the disease, better treatments may be identified for patients with leukemia.
PRIMARY OBJECTIVE: To identify variants in genes that are inherited, have altered gene
structure and/or function, and influence the risk of developing acute lymphoblastic leukemia
(ALL) and other cancers.
SECONDARY OBJECTIVE: To collect demographic, clinical and laboratory information including
detailed family cancer history and response of cancers to therapy for correlation with the
primary objective.
predisposition syndromes have been described, the nature of inherited genetic alterations in
patients with a strong history of familial cancer is currently unknown, as is the case with
childhood acute lymphoblastic leukemia (ALL).
The investigators are seeking to learn more about what causes leukemia and why some people
and families may be at a higher risk of developing this disease. By understanding the origin
of the disease, better treatments may be identified for patients with leukemia.
PRIMARY OBJECTIVE: To identify variants in genes that are inherited, have altered gene
structure and/or function, and influence the risk of developing acute lymphoblastic leukemia
(ALL) and other cancers.
SECONDARY OBJECTIVE: To collect demographic, clinical and laboratory information including
detailed family cancer history and response of cancers to therapy for correlation with the
primary objective.
This study entails clinical interviews, submission of a peripheral germline blood sample for
non-tumor DNA and permission to perform biologic studies on previously stored tumor tissue if
applicable and available. Participants diagnosed with cancer at outside institutions will be
requested to sign a release form to allow the outside institution to send germline and/or
tumor tissue to St Jude if available. For patients who have undergone a stem cell transplant,
a buccal swab or saliva sample will be requested (for germline DNA). For patients with active
leukemia, non-tumor cells (for germline DNA) may be obtained using a remission blood sample,
a skin biopsy (to obtain fibroblasts) or may be purified by fluorescence activated cell
sorting of leukemia samples. The skin biopsy will be obtained in participants 18 years of age
and older. In participants less than 18 years, the skin biopsy will be accessed only if it
was already collected as part of another research protocol or for clinical care.
All patients being considered for enrollment will have a clinical genetics consult by one of
the study team members at which time a family history will be taken and information about
genomic testing will be introduced. Detailed medical history will be obtained which includes
but is not limited to demographics, clinical data including laboratory results, cancer
history/diagnosis, treatment outcomes, environmental exposures and cancer risk factors to
enable phenotype/genotype correlations.
non-tumor DNA and permission to perform biologic studies on previously stored tumor tissue if
applicable and available. Participants diagnosed with cancer at outside institutions will be
requested to sign a release form to allow the outside institution to send germline and/or
tumor tissue to St Jude if available. For patients who have undergone a stem cell transplant,
a buccal swab or saliva sample will be requested (for germline DNA). For patients with active
leukemia, non-tumor cells (for germline DNA) may be obtained using a remission blood sample,
a skin biopsy (to obtain fibroblasts) or may be purified by fluorescence activated cell
sorting of leukemia samples. The skin biopsy will be obtained in participants 18 years of age
and older. In participants less than 18 years, the skin biopsy will be accessed only if it
was already collected as part of another research protocol or for clinical care.
All patients being considered for enrollment will have a clinical genetics consult by one of
the study team members at which time a family history will be taken and information about
genomic testing will be introduced. Detailed medical history will be obtained which includes
but is not limited to demographics, clinical data including laboratory results, cancer
history/diagnosis, treatment outcomes, environmental exposures and cancer risk factors to
enable phenotype/genotype correlations.
Inclusion Criteria:
- Patient with acute lymphoblastic leukemia (ALL) and has a relative also diagnosed with
ALL. Note: There is no upper age limit, and the index ALL case does not have to be a
patient diagnosed and/or treated at St. Jude.
- Family members of the patient, either affected or unaffected by a malignancy, who are
contacted by the patient (or guardian) and agree to participate in the study.
Relatives may have been diagnosed with other malignant, genetic or developmental
disorders.
- Research participant or legal guardian, as appropriate, must provide informed consent
for this protocol.
We found this trial at
1
site
262 Danny Thomas Pl
Memphis, Tennessee 38105
Memphis, Tennessee 38105
(901) 495-3300
Principal Investigator: John T. Sandlund, M.D.
Phone: 866-278-5833
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