An observational study in Breast Neoplasms, Ischemia-Reperfusion Injury and Postoperative Complications, sponsored by Hubei Cancer Hospital. Recruiting at 1 site in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-04-03.
Sponsored by Hubei Cancer Hospital · Observational
Brief Summary This observational study will follow patients who undergo DIEP flap breast reconstruction to better understand a common surgical challenge called ischemia-reperfusion (I/R) injury. I/R injury can happen when a flap has a period without blood flow (ischemia) and then blood flow returns (reperfusion). This process may trigger inflammation and oxidative stress and is associated with fat necrosis or partial flap loss.
1. What is being studied
2. Who can take part
3. What will happen if you join
4. Risks and benefits
5. Privacy and data protection
6. Time commitment and costs
7. Voluntary participation Joining the study is voluntary. Participants may withdraw at any time without affecting their medical care.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 30 is below the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Hubei Cancer Hospital is the lead sponsor of 25 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Hospitalized adult women (18-70 years) with breast cancer at Hubei Cancer Hospital undergoing mastectomy with immediate DIEP free-flap breast reconstruction. Approximately 30 consecutive eligible patients able to provide written informed consent will be enrolled. Exclusions include severe cardiac/hepatic/renal dysfunction or severe coagulopathy, preoperative active infection, autoimmune disease or chronic immunosuppressive/anti-inflammatory therapy (e.g., corticosteroids), pregnancy or breastfeeding, and prior ipsilateral breast surgery or radiotherapy. This is an observational perioperative biomarker cohort; no investigational agents or devices are administered.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Prospective observational cohort of women (18-70 years) undergoing immediate autologous breast reconstruction with a DIEP free flap. Standard peri-operative care only; no investigational imaging or drug (no Mn/QD-SAC) is administered. Serial peripheral blood is collected at pre-op baseline (≤24 h) and at 0 h, 6 h, 24 h, and 72 h post-op (≈10 mL/timepoint; serum + EDTA plasma). Primary measurement is plasma IL-6; additional analytes include IL-1β, TNF-α, IL-8, IL-10, IL-18, HMGB1, vWF, VEGF, HIF-1α, MDA, 8-iso-PGF2α, SOD, CAT, GSH-Px, lactate, LDH, PT/APTT/fibrinogen, D-dimer, and CBC. Samples are processed within 2 h and stored at -80°C for batch ELISA/biochemical assays. Clinical data (age, BMI, operative/ischemia times, flap perfusion assessments, complications, fat necrosis/partial flap loss) are recorded. Target enrollment \~30 participants.
Viable DIEP flap area (%) at postoperative day 7
Standardized digital photographs will be obtained on POD7 under uniform lighting and distance with a calibration ruler. Viable flap area (%) is calculated as \[viable area/total area\]×100 using blinded planimetry by two independent raters; discrepancies \>5% are adjudicated by a third rater. This endpoint reflects clinical benefit and flap survival. This is a co-primary endpoint with IL-6; the family-wise error rate is controlled at 0.05 using the Bonferroni correction (two-sided α=0.025 per endpoint).
Time frame: Postoperative day 7
Plasma interleukin-6 (IL-6) concentration at 24 hours after surgery
Plasma IL-6 (pg/mL) will be quantified in EDTA plasma using a validated sandwich enzyme-linked immunosorbent assay (ELISA). Blood is drawn up to 24 hours prior to surgery (baseline) and at 24 hours after surgery; plasma is separated within 2 hours, aliquoted, and stored at -80°C (single freeze-thaw). Samples are run in duplicate with a 7-point standard curve and quality control samples. The co-primary analysis will focus on the change in IL-6 from baseline to 24 hours post-surgery, analyzed as a continuous variable with prespecified covariates (age, body mass index, ischemia time, operative duration). This endpoint is co-primary with flap viability; the Bonferroni-adjusted family-wise error rate is 0.05 (two-sided alpha=0.025).
Time frame: Baseline (up to 24 hours before surgery) and 24 hours after surgery.
Plasma tumor necrosis factor alpha (TNF-α) concentration at 24 hours after surgery
EDTA plasma TNF-α (pg/mL) will be quantified using a validated sandwich ELISA. Blood is drawn up to 24 hours prior to surgery (baseline) and at 24 hours after surgery; plasma is processed within 2 hours, aliquoted, and stored at -80°C (single freeze-thaw). Samples are run in duplicate. The primary analysis will assess the change in TNF-α from baseline to 24 hours post-surgery as a continuous variable.
Time frame: Baseline (up to 24 hours before surgery) and 24 hours after surgery.
Plasma interleukin-10 (IL-10) concentration at 24 hours after surgery
EDTA plasma IL-10 (pg/mL) will be quantified using a validated sandwich ELISA. Blood is drawn up to 24 hours prior to surgery (baseline) and at 24 hours after surgery; plasma is separated within 2 hours, aliquoted, and stored at -80°C (single freeze-thaw). Samples are run in duplicate. The analysis will focus on the change in IL-10 concentration from baseline to 24 hours post-surgery as a continuous variable.
Time frame: Baseline (up to 24 hours before surgery) and 24 hours after surgery.
Area under the curve (AUC) for plasma malondialdehyde from baseline to 24 hours after surgery
Plasma malondialdehyde will be measured using a validated thiobarbituric acid reactive substances assay. Blood is collected up to 24 hours prior to surgery (baseline), and at 6 hours and 24 hours after surgery; plasma is processed within 2 hours, aliquoted, and stored at -80°C (single freeze-thaw). The area under the concentration-time curve from baseline to 24 hours after surgery will be calculated using the linear trapezoidal method based on the values at the three time points, and analyzed as a continuous variable.
Time frame: Baseline (up to 24 hours before surgery), 6 hours after surgery, and 24 hours after surgery.
Area under the curve (AUC) for plasma superoxide dismutase activity from baseline to 24 hours after surgery
Superoxide dismutase activity will be measured using a validated enzymatic activity kit. Blood collection and processing as per Outcome 5. The AUC from baseline to 24 hours will be calculated and analyzed separately as a continuous variable.
Time frame: Baseline (up to 24 hours before surgery), 6 hours after surgery, and 24 hours after surgery.
Area under the curve (AUC) for plasma glutathione peroxidase activity from baseline to 24 hours after surgery
Glutathione peroxidase activity will be measured using a validated enzymatic activity kit. Blood collection and processing as per Outcome 5. The AUC from baseline to 24 hours will be calculated and analyzed separately as a continuous variable.
Time frame: Baseline (up to 24 hours before surgery), 6 hours after surgery, and 24 hours after surgery.
Number of participants with surgical site infection within 30 days
Infection at the flap or donor site meeting CDC criteria (e.g., purulent drainage, positive culture, or surgeon diagnosis requiring treatment). Data will be captured prospectively from medical records and follow-up visits.
Time frame: From surgery to postoperative day 30
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — IPD will not be shared due to patient privacy and ethical considerations, absence of consent for data sharing, institutional/regulatory restrictions, and limited resources for secure de-identification and data hosting. Aggregate results will be available in publications or upon request.
Started Dec 2025 (actual). Primary completion is estimated for Sep 2026, 9 months after the start.
Of 1,191 non-industry observational studies under Breast Neoplasms, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 139. This study's planned 9 months is below that.
Counting every sponsor, half of 1,380 studies reached it within 55 months; a quarter within 25 and three quarters within 126.
How these figures are worked out, and which studies are left out of them.
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Hubei Cancer Hospital