CancerPhase 3NCT00180869
Unmodified Versus Leuko-reduced Allogeneic Red Blood Cells Transfusion in Cancer Patients
A Phase 3 study testing transfusion of allogeneic red blood cell concentrate and transfusion of leuko-reduced red blood cell concentrate in people with Cancer and Surgery, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
There is evidence to suggest that red blood cell concentrate (RBC) transfusion may have immunomodulatory effects. The aim of this randomized single-center trial is to compare immune responses in patients undergoing cancer surgery and given either an unmodified RBC (UN-RBC) or a leuko-reduced RBC (LR-RBC) transfusion… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- What is being tested?
- transfusion of allogeneic red blood cell concentrate and transfusion of leuko-reduced red blood cell concentrate
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- Sep 1997to not given
- Phase
- Phase 3
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Surgery for cancer with a transfusion during surgery risk greater than 30%
- Surgery in curative intent
- Written informed consent
Who cannot join
- contraindications to the use of allogeneic unmodified red blood cell concentrate
- any anti-RBC and/or anti-HLA and/or anti-granulocyte alloimmunization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Study of Unmodified Versus Leuko-reduced Allogeneic Red Blood Cells Transfusion During Surgery in Cancer Patients
There is evidence to suggest that red blood cell concentrate (RBC) transfusion may have immunomodulatory effects. The aim of this randomized single-center trial is to compare immune responses in patients undergoing cancer surgery and given either an unmodified RBC (UN-RBC) or a leuko-reduced RBC (LR-RBC) transfusion perioperatively.
Read the detailed description
This single-center study is conducted to compare the effect of peroperative transfusion of allogeneic unmodified RBC (UN-RBC) versus leuko-reduced RBC (RED-RBC) on recipient immunity. Patients undergoing cancer surgery are randomly assigned peroperatively to receive UN-RBC or RED-RBC. Groups are stratified for age, sex, tumor characteristics, prior transfusion and prior cancer treatment. Blood sampless are collected before anesthesia (d0) and at days 3, 7, 14 , 28 after transfusion/surgery and analyzed for complete cell blood count, lymphocyte subsets, cytokine production (IL4, IL10, IFNgamma, IL12), T-cells repertoire (TCR) analysis and detection of circulating donor cells. Main study endpoint is the influence of the treatment arm on IL4/IFNgamma ratio. The effect of transfusion type on any given biological parameters is also tested (peripheral blood mononuclear cell phenotyping (PBMC), cytokine production by stimulated PBMC, T cell repertoire analysis and microchimerism assessment).
- Being tested
- transfusion of allogeneic red blood cell concentrate, transfusion of leuko-reduced red blood cell concentrate
- Keywords
- cancer, peroperative transfusion, allogeneic red blood cell concentrate, leuko-reduced red blood cell concentrate
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transfusion of allogeneic red blood cell concentrateProcedure or surgery
transfusion of leuko-reduced red blood cell concentrateProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Polarization of lymphocyte responses towards a Th2 response following transfusion during surgery as assessed by the IL-4/IFN-γ ratio
Secondary outcomes (6)
Peripheral blood mononuclear cell phenotyping
Cytokine production
Microchimerism at day 3 after transfusion during surgery
Alteration of T cell repertoire
Incidence of nosocomial infection
Survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startSep 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valerie Lapierre, PhD, Principal investigator, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00180869
- Sponsor's protocol ID
- TRANSFUGE
- Status last verified
- Aug 2026
- First submitted
- 12 Sep 2005
- Last updated
- 19 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lapierre V, Auperin A, Robinet E, Ferrand C, Oubouzar N, Tramalloni D, Saas P, Debaene B, Lasser P, Tiberghien P. Immune modulation and microchimerism after unmodified versus leukoreduced allogeneic red blood cell transfusion in cancer patients: results of a randomized study. Transfusion. 2007 Sep;47(9):1691-9. doi: 10.1111/j.1537-2995.2007.01344.x.
PubMed 17725736
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of Unmodified Versus Leuko-reduced Allogeneic Red Blood Cells Transfusion During Surgery in Cancer Patients
- ClinicalTrials.gov ID
- NCT00180869
- Acronym / sponsor ID
- TRANSFUGE
- Keywords
- cancer, peroperative transfusion, allogeneic red blood cell concentrate, leuko-reduced red blood cell concentrate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- Sep 1997
- First posted
- 16 Sep 2005 (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.
There is evidence to suggest that red blood cell concentrate (RBC) transfusion may have immunomodulatory effects. The aim of this randomized single-center trial is to compare immune responses in patients undergoing cancer surgery and given either an unmodified RBC (UN-RBC) or a leuko-reduced RBC (LR-RBC) transfusion perioperatively.
Detailed description
This single-center study is conducted to compare the effect of peroperative transfusion of allogeneic unmodified RBC (UN-RBC) versus leuko-reduced RBC (RED-RBC) on recipient immunity. Patients undergoing cancer surgery are randomly assigned peroperatively to receive UN-RBC or RED-RBC. Groups are stratified for age, sex, tumor characteristics, prior transfusion and prior cancer treatment. Blood sampless are collected before anesthesia (d0) and at days 3, 7, 14 , 28 after transfusion/surgery and analyzed for complete cell blood count, lymphocyte subsets, cytokine production (IL4, IL10, IFNgamma, IL12), T-cells repertoire (TCR) analysis and detection of circulating donor cells. Main study endpoint is the influence of the treatment arm on IL4/IFNgamma ratio. The effect of transfusion type on any given biological parameters is also tested (peripheral blood mononuclear cell phenotyping (PBMC), cytokine production by stimulated PBMC, T cell repertoire analysis and microchimerism assessment).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Surgery for cancer with a transfusion during surgery risk greater than 30%
- Surgery in curative intent
- Written informed consent
Key exclusion criteria (2 listed)
- contraindications to the use of allogeneic unmodified red blood cell concentrate
- any anti-RBC and/or anti-HLA and/or anti-granulocyte alloimmunization
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 |
|---|---|---|
| transfusion of allogeneic red blood cell concentrate | Procedure or surgery | – |
| transfusion of leuko-reduced red blood cell concentrate | Procedure or surgery | – |
Primary outcome
Polarization of lymphocyte responses towards a Th2 response following transfusion during surgery as assessed by the IL-4/IFN-γ ratio
6 secondary outcomes
Peripheral blood mononuclear cell phenotyping
Cytokine production
Microchimerism at day 3 after transfusion during surgery
Alteration of T cell repertoire
Incidence of nosocomial infection
Survival
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 Aug 2026.
- Results publication: PubMed 17725736Lapierre V, Auperin A, Robinet E, Ferrand C, Oubouzar N, Tramalloni D, Saas P, Debaene B, Lasser P, Tiberghien P. Immune modulation and microchimerism after unmodified versus leukoreduced allogeneic red blood cell transfusion in cancer patients: results of a randomized study. Transfusion. 2007 Sep;47(9):1691-9. doi: 10.1111/j.1537-2995.2007.01344.x.
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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.
Valerie Lapierre, PhD principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing transfusion of allogeneic red blood cell concentrate and transfusion of leuko-reduced red blood cell concentrate in people with Cancer and Surgery, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
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 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 Aug 2026. 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 France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Polarization of lymphocyte responses towards a Th2 response following transfusion during surgery as assessed by the IL-4/IFN-γ ratio. 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 NCT00180869, which also lists 1 linked publication.
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 Aug 2026.