AnemiaNCT06928558
Preoperative Anemia in the Oncology Population and Associated Mortality
An observational study of Anemia and Oncologic Surgery, run by University of Chile.
Trial summary
Anemia is a highly prevalent condition in the surgical population (1, 2). On the other hand, the oncology population is at higher risk of developing anemia due to specific treatments for the disease, such as chemotherapy and radiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Oncologic Surgery
- How many people
- 850 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2025to 15 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Consecutive patients operated at the National Cancer Institute will be included in a retrospective cohort study between January and December 2022.
Who may be able to join
- Patients over 18 years of age
- Oncologic surgery with curative intent
Who cannot join
- Emergency surgery
- Patients who received a preoperative transfusion
- Patients without a preoperative blood count
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prevalence of Preoperative Anemia in the Oncology Population and Associated Mortality
Anemia is a highly prevalent condition in the surgical population (1, 2). On the other hand, the oncology population is at higher risk of developing anemia due to specific treatments for the disease, such as chemotherapy and radiotherapy. Preoperative anemia has been associated with an increased risk of postoperative morbidity and even mortality (3). Despite this, the prevalence of preoperative anemia in the Chilean oncology population has not been quantified. To answer this question, a retrospective cohort study was designed between January and December 2022 to quantify the prevalence of anemia in the surgical population of the National Cancer Institute. In addition, the impact on morbidity and mortality at 30 days, 6 months, and 1 year will be evaluated. Statistical analysis will be performed using R. Studio Version 2023.09.1+494 (2023.09.1+494).
Read the detailed description
General Objective:
To quantify the prevalence of preoperative anemia in the National Cancer Institute's oncology surgical population and its impact on postoperative outcomes.
Specific Objectives:
- To quantify the prevalence of preoperative anemia in the National Cancer Institute's oncology population.
- To stratify the prevalence of preoperative anemia in the National Cancer Institute's oncology population by severity.
- To assess 30-day, 6-month, and 1-year mortality in cancer patients with and without anemia in the National Cancer Institute's oncology population.
- Conditions
- Anemia, Oncologic Surgery
- Keywords
- Anemia, Oncologic Surgery, Anesthesia
- Medical subject headings
- Anemia
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 |
|---|---|---|
| Surgical oncology patients | Oncology patients over 18 years of age, scheduled for surgery with curative intent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of preoperative anemia
To quantify the prevalence of preoperative anemia in the oncology surgical population of the National Cancer Institute and its impact on postoperative outcomes.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start15 Apr 2025 (estimated)
- Primary completion15 May 2025 (estimated)
- Study completion15 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies 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
- Retrospective
- Enrolment
- 850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Gonzalez Cornejo, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06928558
- Sponsor's protocol ID
- Instituto Nacional del Cáncer
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sim YE, Abdullah HR. Implications of Anemia in the Elderly Undergoing Surgery. Clin Geriatr Med. 2019 Aug;35(3):391-405. doi: 10.1016/j.cger.2019.04.001. Epub 2019 May 27.
PubMed 31230739Goodnough LT, Shander A, Spivak JL, Waters JH, Friedman AJ, Carson JL, Keating EM, Maddox T, Spence R. Detection, evaluation, and management of anemia in the elective surgical patient. Anesth Analg. 2005 Dec;101(6):1858-1861. doi: 10.1213/01.ANE.0000184124.29397.EB.
PubMed 16301274Musallam KM, Tamim HM, Richards T, Spahn DR, Rosendaal FR, Habbal A, Khreiss M, Dahdaleh FS, Khavandi K, Sfeir PM, Soweid A, Hoballah JJ, Taher AT, Jamali FR. Preoperative anaemia and postoperative outcomes in non-cardiac surgery: a retrospective cohort study. Lancet. 2011 Oct 15;378(9800):1396-407. doi: 10.1016/S0140-6736(11)61381-0. Epub 2011 Oct 5.
PubMed 21982521
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Preoperative Anemia in the Oncology Population and Associated Mortality
- ClinicalTrials.gov ID
- NCT06928558
- Acronym / sponsor ID
- Instituto Nacional del Cáncer
- Conditions
- Anemia, Oncologic Surgery
- Keywords
- Anemia, Oncologic Surgery, Anesthesia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- 15 Apr 2025 (estimated)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 15 Jun 2025 (estimated)
- First posted
- 15 Apr 2025 (actual)
- 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.
Anemia is a highly prevalent condition in the surgical population (1, 2). On the other hand, the oncology population is at higher risk of developing anemia due to specific treatments for the disease, such as chemotherapy and radiotherapy. Preoperative anemia has been associated with an increased risk of postoperative morbidity and even mortality (3). Despite this, the prevalence of preoperative anemia in the Chilean oncology population has not been quantified. To answer this question, a retrospective cohort study was designed between January and December 2022 to quantify the prevalence of anemia in the surgical population of the National Cancer Institute. In addition, the impact on morbidity and mortality at 30 days, 6 months, and 1 year will be evaluated. Statistical analysis will be performed using R. Studio Version 2023.09.1+494 (2023.09.1+494).
Detailed description
General Objective:
To quantify the prevalence of preoperative anemia in the National Cancer Institute's oncology surgical population and its impact on postoperative outcomes.
Specific Objectives:
- To quantify the prevalence of preoperative anemia in the National Cancer Institute's oncology population.
- To stratify the prevalence of preoperative anemia in the National Cancer Institute's oncology population by severity.
- To assess 30-day, 6-month, and 1-year mortality in cancer patients with and without anemia in the National Cancer Institute's oncology population.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical oncology patients | – | –Oncology patients over 18 years of age, scheduled for surgery with curative intent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients operated at the National Cancer Institute will be included in a retrospective cohort study between January and December 2022.
Key inclusion criteria (2 listed)
- Patients over 18 years of age
- Oncologic surgery with curative intent
Key exclusion criteria (3 listed)
- Emergency surgery
- Patients who received a preoperative transfusion
- Patients without a preoperative blood count
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
Prevalence of preoperative anemia
Time frame: 1 year
To quantify the prevalence of preoperative anemia in the oncology surgical population of the National Cancer Institute and its impact on postoperative outcomes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Background: PubMed 31230739Sim YE, Abdullah HR. Implications of Anemia in the Elderly Undergoing Surgery. Clin Geriatr Med. 2019 Aug;35(3):391-405. doi: 10.1016/j.cger.2019.04.001. Epub 2019 May 27.
- Results publication: PubMed 16301274Goodnough LT, Shander A, Spivak JL, Waters JH, Friedman AJ, Carson JL, Keating EM, Maddox T, Spence R. Detection, evaluation, and management of anemia in the elective surgical patient. Anesth Analg. 2005 Dec;101(6):1858-1861. doi: 10.1213/01.ANE.0000184124.29397.EB.
- Results publication: PubMed 21982521Musallam KM, Tamim HM, Richards T, Spahn DR, Rosendaal FR, Habbal A, Khreiss M, Dahdaleh FS, Khavandi K, Sfeir PM, Soweid A, Hoballah JJ, Taher AT, Jamali FR. Preoperative anaemia and postoperative outcomes in non-cardiac surgery: a retrospective cohort study. Lancet. 2011 Oct 15;378(9800):1396-407. doi: 10.1016/S0140-6736(11)61381-0. Epub 2011 Oct 5.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia and Oncologic Surgery, run by University of Chile.
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 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: opening soon, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roberto A González, MD (+56999397515, robgonzalez@uchile.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of preoperative anemia (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06928558, which also lists 3 linked publications.
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 15 Apr 2025.