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CompletedNCT00322634Updated Sep 19, 2012

Clinical Predictors of Survival in Cancer Patients With Metastatic Solid Tumors

An observational study in Cancer, sponsored by New Mexico Cancer Research Alliance. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-09-19.

Sponsored by New Mexico Cancer Research Alliance · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
25
Ages
18 Years and older
Sex
All
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Study 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 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.

02

Conditions studied

  • Cancer
03

In context

Lead sponsor

New Mexico Cancer Research Alliance is the lead sponsor of 70 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with metastatic solid tumors.

Inclusion criteria

  1. All patients must be at least 18 years of age
  2. All patients must have documented incurable metastatic cancer
  3. 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:

    1. Non-small cell lung cancer patients after third systemic therapy
    2. Small cell lung cancer patients after second systemic therapy
    3. Breast cancer patients after third cytotoxic therapy (does not include hormonal therapy)
    4. Colorectal cancer patients after second systemic therapy
    5. Hormone refractory prostate cancer patients after first cytotoxic therapy
    6. Cancer of unknown primary
    7. Pancreatic cancer patients after first systemic therapy
  4. The use of systemic (chemotherapy, immunotherapy) or local treatments (XRT) for palliation of symptoms is allowed
  5. Patients with a history of previous cancers are allowed
  6. Patients with a history of other significant disease (e.g. heart disease, COPD, etc.) are allowed
  7. All patients must sign informed consent

Exclusion criteria

Exclusion Criteria:

  1. Patients with acute or chronic leukemia, Hodgkin's disease, or non-Hodgkins lymphoma are excluded
  2. Patients who do not sign informed consent are excluded
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
25 participants (actual)
06

What researchers measure

Primary outcomes

  1. Disease Progression

    Time frame: 2 years

07

Study locations

5 sites
  • Hematology Oncology Associates
    Albuquerque, New Mexico 87102-3661, United States
  • Radiation Oncology Associates
    Albuquerque, New Mexico 87111, United States
  • University of New Mexico
    Albuquerque, New Mexico 87131, United States
  • New Mexico Cancer Care Associates
    Santa Fe, New Mexico 87505, United States
  • St. Vincent Regional Medical Center
    Santa Fe, New Mexico 87505, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00322634
Lead sponsor
New Mexico Cancer Research Alliance
Responsible party
Sponsor
First posted
May 8, 2006
Start date
Feb 2006
Primary completion
Jul 2011
Completion
Jul 2011
Last update
Sep 19, 2012

Study contacts

Malcolm Purdy, MD
principal investigator · Hematology & Oncology Associates

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.

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