Acute Lymphoblastic LeukemiaNCT01565447
Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma Gait Parameters Study
An observational study of Acute Lymphoblastic Leukemia and Childhood Lymphoblastic Lymphoma, run by Oregon Health and Science University at 1 site in United States.
Trial summary
This purpose of this study it to characterize the walking patterns of children diagnosed with Acute Lymphoblastic Leukemia (ALL)and Lymphoblastic Lymphoma (LL) at different times in the treatment protocol and after completion of treatment. Read more about this study
- Who is it for?
- Ages 2 to 27 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Childhood Lymphoblastic Lymphoma
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to 20 Mar 2023
- 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 2 to 27 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children diagnosed with ALL or LL and are currently undergoing treatment for or have survived treatment and are no more than 10 years post completion of treatment
Who may be able to join
- Age 2-27 years of age
- Diagnosis of acute lymphoblastic leukemia or lymphoblastic lymphoma
- Currently undergoing treatment for ALL or LL or completed treatment for ALL or LL in the last 10 years.
Who cannot join
- Relapsed ALL or LL
- Received a stem cell transplant, either autologous or allogeneic
- Non ambulatory status prior to diagnosis of acute lymphoblastic leukemia or lymphoblastic lymphoma
Trial locations and contacts
1 site in 1 country.
United States1 site
Doernbecher Children Hospital
Portland, Oregon, 97239
About this study
Official title: Temporal and Spatial Gait Parameters of Children Undergoing Treatment for and Surviving Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma
This purpose of this study it to characterize the walking patterns of children diagnosed with Acute Lymphoblastic Leukemia (ALL)and Lymphoblastic Lymphoma (LL) at different times in the treatment protocol and after completion of treatment. Their walking patterns will be compared to children without ALL or LL to see if their walking patterns are different at specific times in their treatment program or up to 10 years after completion of their treatment. The investigators will gather data by observing how the child walks, runs, hops on one foot and climbs stairs and by recording walking patterns on a pressure sensitive mat. The investigators will compare this data to children without ALL and LL.
Read the detailed description
Cases will be identified and referred by the primary oncologist or by the Childhood Cancer Survivorship team. When a possible subject has been identified they will be contacted via telephone or during a routine clinic visit to determine their interest in the study. Two hundred subjects will be recruited for participation with the goal of 5-10 subjects at each of the 14 times points across the treatment protocol and survivorship. These time points to include: at diagnosis, the start of consolidation therapy, the start of interim maintenance therapy, the start of delayed intensification therapy, Day 29 of delayed intensification therapy, the start of interim maintenance II therapy (if applicable), Day 1 of cycle 1,3,5 of maintenance therapy, end of therapy, and 1, 3, 5, and 10 years off therapy ( +/-1 year).
Clinical data will be collected from the medical record, roadmaps documenting cancer-directed therapy, direct patient interview and examination by the physical therapist during the study evaluation. Clinical data will include: Date of birth (to calculate age at diagnosis and current age); Gender; Race and Ethnicity; Primary cancer diagnosis; Date of Primary Cancer Diagnosis; Chemotherapeutic agents received (agent name, cumulative dose and date received); Radiation therapy (date received, site radiated, and dose delivered); Any other clinical conditions affecting musculoskeletal performance; Dates of previous PT; Pain score at the time of study participation. Height, weight, shoe size and leg length will be collected at time of study participation.
Subjects will complete a self report of the PedsQL™ Generic Core Scale and the parents will complete the parental report.
Observation gait assessment will include hopping on one foot, running and walking 30' and ascending/descending stairs.
Temporal spatial gait parameters will be recorded on the GaitRite mat
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
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 |
|---|---|---|
| Children with ALL or LL | Children diagnosed with ALL or LL will be recruited for this study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temporal and Spatial Gait
To characterize temporal and spatial gait parameters of children with ALL/LL at specific time points during their treatment and survivorship using the GAITRite® evaluation system.
Measured: At diagnosis, start of consolidation tx, the start of interim maintenance tx, the start of delayed intensification tx, Day 29 of delayed intensification tx, the start of interim maintenance II tx (if applicable), Day 1 of cycle, 1,3,5 of maintenance tx.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2012 (estimated)
- Study startDec 2011
- Primary completion20 Mar 2023
- Study completion20 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nancy Durben, Oregon Health and Science University
- Investigators
- Susan Lindemulde, MD, MCR, Study director, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01565447
- Sponsor's protocol ID
- OregonHSU
- Status last verified
- Apr 2023
- First submitted
- 31 Jan 2012
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporal and Spatial Gait Parameters of Children Undergoing Treatment for and Surviving Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma
- ClinicalTrials.gov ID
- NCT01565447
- Acronym / sponsor ID
- OregonHSU
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Dec 2011 (actual)
- Primary completion
- 20 Mar 2023 (actual)
- Study completion
- 20 Mar 2023 (actual)
- First posted
- 28 Mar 2012 (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 purpose of this study it to characterize the walking patterns of children diagnosed with Acute Lymphoblastic Leukemia (ALL)and Lymphoblastic Lymphoma (LL) at different times in the treatment protocol and after completion of treatment. Their walking patterns will be compared to children without ALL or LL to see if their walking patterns are different at specific times in their treatment program or up to 10 years after completion of their treatment. The investigators will gather data by observing how the child walks, runs, hops on one foot and climbs stairs and by recording walking patterns on a pressure sensitive mat. The investigators will compare this data to children without ALL and LL.
Detailed description
Cases will be identified and referred by the primary oncologist or by the Childhood Cancer Survivorship team. When a possible subject has been identified they will be contacted via telephone or during a routine clinic visit to determine their interest in the study. Two hundred subjects will be recruited for participation with the goal of 5-10 subjects at each of the 14 times points across the treatment protocol and survivorship. These time points to include: at diagnosis, the start of consolidation therapy, the start of interim maintenance therapy, the start of delayed intensification therapy, Day 29 of delayed intensification therapy, the start of interim maintenance II therapy (if applicable), Day 1 of cycle 1,3,5 of maintenance therapy, end of therapy, and 1, 3, 5, and 10 years off therapy ( +/-1 year).
Clinical data will be collected from the medical record, roadmaps documenting cancer-directed therapy, direct patient interview and examination by the physical therapist during the study evaluation. Clinical data will include: Date of birth (to calculate age at diagnosis and current age); Gender; Race and Ethnicity; Primary cancer diagnosis; Date of Primary Cancer Diagnosis; Chemotherapeutic agents received (agent name, cumulative dose and date received); Radiation therapy (date received, site radiated, and dose delivered); Any other clinical conditions affecting musculoskeletal performance; Dates of previous PT; Pain score at the time of study participation. Height, weight, shoe size and leg length will be collected at time of study participation.
Subjects will complete a self report of the PedsQL™ Generic Core Scale and the parents will complete the parental report.
Observation gait assessment will include hopping on one foot, running and walking 30' and ascending/descending stairs.
Temporal spatial gait parameters will be recorded on the GaitRite mat
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with ALL or LL | – | –Children diagnosed with ALL or LL will be recruited for this study |
Who may qualify
- Ages
- 2 to 27 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children diagnosed with ALL or LL and are currently undergoing treatment for or have survived treatment and are no more than 10 years post completion of treatment
Key inclusion criteria (3 listed)
- Age 2-27 years of age
- Diagnosis of acute lymphoblastic leukemia or lymphoblastic lymphoma
- Currently undergoing treatment for ALL or LL or completed treatment for ALL or LL in the last 10 years.
Key exclusion criteria (3 listed)
- Relapsed ALL or LL
- Received a stem cell transplant, either autologous or allogeneic
- Non ambulatory status prior to diagnosis of acute lymphoblastic leukemia or lymphoblastic lymphoma
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
Temporal and Spatial Gait
Time frame: At diagnosis, start of consolidation tx, the start of interim maintenance tx, the start of delayed intensification tx, Day 29 of delayed intensification tx, the start of interim maintenance II tx (if applicable), Day 1 of cycle, 1,3,5 of maintenance tx.
To characterize temporal and spatial gait parameters of children with ALL/LL at specific time points during their treatment and survivorship using the GAITRite® evaluation system.
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 18 Apr 2023.
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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.
Susan Lindemulde, MD, MCR study director
Oregon Health and Science University
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 Acute Lymphoblastic Leukemia and Childhood Lymphoblastic Lymphoma, run by Oregon Health and Science University at 1 site 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 3 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: finished, as of the sponsor's last update on 18 Apr 2023. 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 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.
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?
Temporal and Spatial Gait (time frame: At diagnosis, start of consolidation tx, the start of interim maintenance tx, the start of delayed intensification tx, Day 29 of delayed intensification tx, the start of interim maintenance II tx (if applicable), Day 1 of cycle, 1,3,5 of maintenance tx.). 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 18 Apr 2023.