CancerNCT00322634
Clinical Predictors of Survival in Cancer Patients With Metastatic Solid Tumors
An observational study of Cancer, run by New Mexico Cancer Research Alliance at 5 sites in United States.
Trial summary
The use of performance status and LDH in combination can predict patient survival more accurately than physician clinical impression or the patients' own feelings about their survival Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- How many people
- 25 participants
- Where
- 5 sitesUnited States
- Study dates
- Feb 2006to Jul 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with metastatic solid tumors.
Who may be able to join
- All patients must be at least 18 years of age
- All patients must have documented incurable metastatic cancer
- All patients must have exhausted any treatments which are known to prolong survival in their disease, or have elected not to receive further life-prolonging therapy. Specifically, patients with the following are eligible:
- Non-small cell lung cancer patients after third systemic therapy
- Small cell lung cancer patients after second systemic therapy
- Breast cancer patients after third cytotoxic therapy (does not include hormonal therapy)
Show all 14Show fewer
- Colorectal cancer patients after second systemic therapy
- Hormone refractory prostate cancer patients after first cytotoxic therapy
- Cancer of unknown primary
- Pancreatic cancer patients after first systemic therapy
- The use of systemic (chemotherapy, immunotherapy) or local treatments (XRT) for palliation of symptoms is allowed
- Patients with a history of previous cancers are allowed
- Patients with a history of other significant disease (e.g. heart disease, COPD, etc.) are allowed
- All patients must sign informed consent
Who cannot join
- Patients with acute or chronic leukemia, Hodgkin's disease, or non-Hodgkins lymphoma are excluded
- Patients who do not sign informed consent are excluded
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Hematology Oncology Associates
Albuquerque, New Mexico, 87102-3661
Radiation Oncology Associates
Albuquerque, New Mexico, 87111
University of New Mexico
Albuquerque, New Mexico, 87131
New Mexico Cancer Care Associates
Santa Fe, New Mexico, 87505
St. Vincent Regional Medical Center
Santa Fe, New Mexico, 87505
About this study
Official title: Investigator Initiated Trial: Prospective Study of Clinical Predictors of Survival in Cancer Patients With Metastatic Solid Tumors
The use of performance status and LDH in combination can predict patient survival more accurately than physician clinical impression or the patients' own feelings about their survival
Read the detailed description
Patients with incurable cancer frequently ask their doctors for an estimate of survival. Such estimates can assist patients in making decisions about how best to spend their time and energy. Survival estimates are also required when considering patients with incurable cancer for experimental treatments. However, such estimates are difficult to make. There is some data to suggest that a simple clinical measure, the performance status, combined with a laboratory blood test, the LDH, may assist in making the survival estimate more realistic. This study is designed to test if this is the case, using patients with metastatic lung, breast, colorectal, prostate, or pancreatic cancer or patients with cancer of unknown primary who have exhausted life-prolonging therapy. These patients will be asked to consent to entering this study. Their performance status will be assessed by the Karnofsky and WHO scales, they will be asked to have their blood tested for LDH and they and their doctor will be asked to estimate their survival. After study entry they will be allowed to receive palliative radiotherapy, surgery or systemic therapy as indicated including protocol treatment. After study entry, the only other requirement is that the date of the patients death be reported so that the duration of survival can be compared with the doctors and patients estimate and correlated with the performance status and LDH.
- Conditions
- Cancer
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Progression
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2006 (estimated)
- Study startFeb 2006
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- New Mexico Cancer Research Alliance
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malcolm Purdy, MD, Principal investigator, Hematology & Oncology Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00322634
- Sponsor's protocol ID
- INST 0535C
- Status last verified
- Aug 2011
- First submitted
- 5 May 2006
- Last updated
- 19 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigator Initiated Trial: Prospective Study of Clinical Predictors of Survival in Cancer Patients With Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT00322634
- Acronym / sponsor ID
- INST 0535C
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- New Mexico Cancer Research AllianceUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 8 May 2006 (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 use of performance status and LDH in combination can predict patient survival more accurately than physician clinical impression or the patients' own feelings about their survival
Detailed description
Patients with incurable cancer frequently ask their doctors for an estimate of survival. Such estimates can assist patients in making decisions about how best to spend their time and energy. Survival estimates are also required when considering patients with incurable cancer for experimental treatments. However, such estimates are difficult to make. There is some data to suggest that a simple clinical measure, the performance status, combined with a laboratory blood test, the LDH, may assist in making the survival estimate more realistic. This study is designed to test if this is the case, using patients with metastatic lung, breast, colorectal, prostate, or pancreatic cancer or patients with cancer of unknown primary who have exhausted life-prolonging therapy. These patients will be asked to consent to entering this study. Their performance status will be assessed by the Karnofsky and WHO scales, they will be asked to have their blood tested for LDH and they and their doctor will be asked to estimate their survival. After study entry they will be allowed to receive palliative radiotherapy, surgery or systemic therapy as indicated including protocol treatment. After study entry, the only other requirement is that the date of the patients death be reported so that the duration of survival can be compared with the doctors and patients estimate and correlated with the performance status and LDH.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic solid tumors.
Key inclusion criteria (14 listed)
- All patients must be at least 18 years of age
- All patients must have documented incurable metastatic cancer
- All patients must have exhausted any treatments which are known to prolong survival in their disease, or have elected not to receive further life-prolonging therapy. Specifically, patients with the following are eligible:
- The use of systemic (chemotherapy, immunotherapy) or local treatments (XRT) for palliation of symptoms is allowed
- Patients with a history of previous cancers are allowed
Key exclusion criteria (2 listed)
- Patients with acute or chronic leukemia, Hodgkin's disease, or non-Hodgkins lymphoma are excluded
- Patients who do not sign informed consent are excluded
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
Disease Progression
Time frame: 2 years
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 19 Sep 2012.
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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.
Malcolm Purdy, MD principal investigator
Hematology & Oncology Associates
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by New Mexico Cancer Research Alliance at 5 sites 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 14 inclusion and 2 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 19 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Disease Progression (time frame: 2 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 19 Sep 2012.