Hematopoietic and Lymphoid Cell NeoplasmNCT00507572
Collection of Outcomes Data for Pregnant Patients With Cancer
An observational study of Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This study collects treatment and outcomes information on pregnant patients who are or were pregnant with cancer. Gathering and storing health information on pregnant patients with cancer, may provide data for future research studies and improve patient care. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Medical Chart Review
- How many people
- 313 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2005to 8 Aug 2025
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pregnant patients with cancer and patients known to have been pregnant with a diagnosis of cancer
Who may be able to join
- All pregnant patients with cancer and patients known to have been pregnant with a diagnosis of cancer are eligible, regardless of their diagnosis or treatment plan
- Patients may receive prenatal care from any obstetrician, but a consult with Maternal Fetal Medicine is encouraged
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This study collects treatment and outcomes information on pregnant patients who are or were pregnant with cancer. Gathering and storing health information on pregnant patients with cancer, may provide data for future research studies and improve patient care.
Read the detailed description
PRIMARY OBJECTIVES:
- To collect, both prospectively and retrospectively, data on disease characterization, treatment and outcome for pregnant patients with malignancies seen at M. D. Anderson Cancer Center.
II. To organize clinical information in order to support multifaceted queries of patient characteristics, treatment, and pregnancy outcome data and to facilitate correlation of these characteristics with patient outcome.
III. To have a single data repository, kept on a secure platform, that will integrate clinical information and research findings and serve as a secure archive for future research.
OUTLINE:
Patients' medical records are reviewed prospectively and retrospectively.
- Being tested
- Medical Chart Review
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Chart ReviewOther
Also called Chart Review
Medical records are reviewed
| Study group | Role | What they receive |
|---|---|---|
| Observational (medical chart review) | Patients' medical records are reviewed prospectively and retrospectively. Receives: Other: Medical Chart Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creation of data repository for patient characteristics, treatment, and pregnancy outcome data
Measured: Up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2007 (estimated)
- Study start19 Dec 2005
- Primary completion8 Aug 2025
- Study completion8 Aug 2025
Why it stopped: \<75% participation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Case only
- Time perspective
- Other
- Enrolment
- 313 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea M Milbourne, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00507572
- Sponsor's protocol ID
- 2005-0518
- Other IDs
- NCI-2020-07509, 2005-0518
- Status last verified
- Aug 2025
- First submitted
- 24 Jul 2007
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Outcomes Data for Pregnant Patients With Cancer
- ClinicalTrials.gov ID
- NCT00507572
- Acronym / sponsor ID
- 2005-0518
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: \<75% participation
- Enrolment
- 313 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 19 Dec 2005 (actual)
- Primary completion
- 8 Aug 2025 (actual)
- Study completion
- 8 Aug 2025 (actual)
- First posted
- 26 Jul 2007 (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 study collects treatment and outcomes information on pregnant patients who are or were pregnant with cancer. Gathering and storing health information on pregnant patients with cancer, may provide data for future research studies and improve patient care.
Detailed description
PRIMARY OBJECTIVES:
- To collect, both prospectively and retrospectively, data on disease characterization, treatment and outcome for pregnant patients with malignancies seen at M. D. Anderson Cancer Center.
II. To organize clinical information in order to support multifaceted queries of patient characteristics, treatment, and pregnancy outcome data and to facilitate correlation of these characteristics with patient outcome.
III. To have a single data repository, kept on a secure platform, that will integrate clinical information and research findings and serve as a secure archive for future research.
OUTLINE:
Patients' medical records are reviewed prospectively and retrospectively.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (medical chart review) | – | Other: Medical Chart ReviewPatients' medical records are reviewed prospectively and retrospectively. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant patients with cancer and patients known to have been pregnant with a diagnosis of cancer
Key inclusion criteria (2 listed)
- All pregnant patients with cancer and patients known to have been pregnant with a diagnosis of cancer are eligible, regardless of their diagnosis or treatment plan
- Patients may receive prenatal care from any obstetrician, but a consult with Maternal Fetal Medicine is encouraged
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Medical Chart ReviewAlso: Chart ReviewMedical records are reviewed | Other | Observational (medical chart review) |
Primary outcome
Creation of data repository for patient characteristics, treatment, and pregnancy outcome data
Time frame: Up to 15 years
Results and safety
The study was stopped early (reason given: \<75% participation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Andrea M Milbourne principal investigator
M.D. Anderson Cancer Center
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 Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by M.D. Anderson Cancer Center 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 2 inclusion and 0 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 13 Aug 2025. 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 was stopped early (reason given: \<75% participation). 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?
Creation of data repository for patient characteristics, treatment, and pregnancy outcome data (time frame: Up to 15 years). 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 Aug 2025.